Contract Laboratory has received the following incoming Laboratory Test Requests which need to be fulfilled! These Laboratory Test Requests are received from a variety of sources ranging from start-up companies to large, multinational Fortune 500 corporations, international organizations, well-respected universities and government agencies that are actively seeking Independent, Third-Party Medical Laboratories to perform their Medical Testing, Analysis, Assays, Product Development, Scientific Research Experiments, Inspections, Certifications, and Engineering Projects. If you are a Medical laboratory that would like more information on these Medical projects, please visit Register Laboratories or call toll free 1-855-377-6821.
Packaging Laboratory needed for Medical Device Package Design Qualification Testing of a UN 4G Fiberboard Box With 47 x 40 x 1.5-mil poly Red Bag with twist tie and knotted closure This package is not certified for shipment by air. Box Information: 32# ECT (38-26C-38) / D/C Special Design style / ?C? flute / glued joint / Extended design carrying handles / Auto bottom / interlocking top Part Number: 17 x 14 x 19 Outer Dimensions: 18? x 15 ¼? x 20 1/8? (24 ¼?) Inner Dimensions: 17 ¾? x 15? x 19 5/8? Manufacturers Joint: Glued with a 1.25? inside tapered flap Tare Weight: Box: 1.8 lbs. Basis Weights
FDA GLP ISO-17025 bioanalytical laboratory needed for characterization of collagen scaffold medical device including amino acid analysis, quantification of Collagen I, DNA, GAG and lipids, protein assay, and trypsin resistance. residue analysis, hydroxyproline determination,
Medical device company needs clinical product safety laboratory for in-vivo, in-vitro and microbiology testing of disposable feminine pads including:
Surface device testing with just contact to the skin or breached/compromised surface (due to labial contact). We will do a limited exposure (less than 24 hours) testing.
Microbiology testing as pads release oxygen and slightly acidify the pH within the pad once blood reaches our patented powder. We want to see if it has any effect on microbes.
Measure the pH after blood has entered the pad to see how the pH is affected after blood has entered.
Amount of oxygen released per pad, the amount of CO2 absorbed per pad and the amount of humidity absorbed per pad?
URGENT TESTING FDA GMP Medical device preclinical laboratory needed for product safety and toxicity studies of a plastic dental aligner. Risk Assessment in regards to human exposure (oral, dermal, inhalation) is requested for a dental aligner and support-removal media. The dental plastic aligner is thermoformed onto a 3D printed mold that was previously soaked in our support-removal media.
Medical Device preclinical contract research organization CRO needed for insulin characterization with or without infusion through medical device: (1) High molecular weight proteins (insulin aggregates), (2) Preservative content (m-cresol), (3) Impurities, (4) Bioidentity (blood glucose response in rabbits), (5) Zinc content and (6) insulin recovery.
Medical devices laboratory needed for ISO Testing of medical breathing tubing to ISO 5367 Annex A, Annex C, Annex D, Annex E, Annex F, testing of tubing: ANNEX A: RESISTANCE TO AIR FLOW ANNEX D: LEAKAGE ANNEX E: INCREASE IN FLOW RESISTANCE WITH BENDING ANNEX F: COMPLIANCE ANNEX C: SECURITY OF ATTACHMENT OF ADAPTER TO BREATHING TUBE
LONG TERM TESTING FDA cGMP microbiology laboratory needed for USP water testing of water for injection based on USP monograph for Sterile Water for Injection and the European Pharmacopeia (Ph. Eur.) monographs for Water for Injections in bulks and sterilized Water for Injections. Also need extractable volume and uniform volume.
Blood testing laboratory needed for analyzing samples for the following contents: Interleukin-1 beta (IL-1ß1), Erythrocyte sedimentation rate (ESR), High-sensitivity C-reactive protein (hs-CRP), Serum osteocalcin: measured using the ELSAOSTEO radioimmunoassay (IRMA), Serum hyaluronic acid (HA): measured using the Pharmacia HA Test radiometric assay,, Serum Keratin sulphate: measured by ELISA , Transforming growth factor beta (TGF-ß).
Medical Device laboratory needed for ASTM and ISO product safety testing for evaluation of medical devices including toxicology, packaging and microbiology testing:
ASTM D7661-10, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms for compliance with latex and polyisoprene condoms.
ISO 10993-5 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Biological Evaluation of Medical Devices-Part 10: Tests for irritation and skin sensitization
ISO 10993-11 Biological Evaluation of Medical Devices-Part 11: Tests for systemic toxicity
United States Pharmacopeia, National Formulary General Chapter <88>: Biological Reactivity Tests, In Vivo
USP <51> Antimicrobial Effectiveness Testing
USP <61> Microbiological Examination of Nonst
University Researcher needs Clinical laboratory for identification testing for human blood (or serum) of the following substances:1.Acrylamide2.Vinyl Bromide3.Dibromoethylene4.Fluoride Vinyl5.Styrene 7.8 Oxide6.1,2,3-trichloropropane7.Tris (2,3-dibromopropyl) Phosphate8.Benzene9.Ethylene Oxide10.Polychlorinated biphenyls (PCBs)11.PCB dl and Total12.1,3- Butadiene13.Pesticides Not Arsenical14.Diazinon,15.Glyphosate16.Malathion17.Parathion18.TetrachlorvinphoIf that is possible, please send us a quote for 100 tests.
Clinical Contract Research Organization needed for Herpes Simplex Virus HSV 1 clinical study of proprietary dermatology solutions for applying formulation for Herpes Simplex Virus HSV 1 treatment for pre episode and after sore formation resulting rapid healing without postulation and scarring
Analytical chemistry laboratory needed for chromatography testing of caprylic acid using the following protocol: COLUMN TYPE:RTX-1 NON-POLARLENGTH:30 METERSINTERNAL DIAMETER:0.25 mmOVERALL DIAMETER:1.0 mmINITIAL TEMPERATURE:70°CINITIAL TIME:2 MINUTESPROGRAM RATE:4°/MINUTEFINAL TEMPERATURE:250°CFINAL TIME:10 MINUTESTOTAL RUN TIME47 MINUTESINJECTOR TEMPERATURE:200°CDETECTOR TYPE:FLAME IONIZATION
Materials laboratory needed for IEST and ASTM Clean Room Gloves Testing: 1 Tensile Strength ASTM D412 2 Ultimate Elongation ASTM D412 3 Surface Resistivity @50%RH ESD/EOS S11.11 4 MVTR 5 Shedding and extractables - IEST RP-CC005.4 LPC ? 0.5 ?m, Cl?, NO3-, Zn2+, SO42+, Na?, K?, Ca2+, Al3+, Fe3+, Cu2+, Total NVR in IPA
FDA GLP Preclinical Laboratory needed for PCR viral testing of two regenerative drug products and raw materials using Pharmacopeia methods: 1. HIV (anti-HIV (I/II), 2. Human T-Lymphotropic virus I and II 3. Cytomegalovirus 4. Epstein-Bar virus 5. Hepatitis C 6. HBV (HBsAg & anti-HBC)
In order to stay in line with the pharmacopeia guidelines, we would like to perform detection of the former viruses on our products with the PCR method.
Clinical Research Organization associated with digestive health needs GLP compliant laboratory for multiple urine, faecal, blood and gene testing Gene qPCR and metagenomics: IL-1 IL-6 IL-8 IL-10 IL-12p70 TNF and Myeloperoxidase Urine samples for Lactulose, Rhamnose, Uric acid, Vitamin C And Blood samples for Calprotectin, Uric acid, Vitamin C, Bacterial 16S rRNA, Faecal samples for Calprotectin, Gene qPCR and metagenomics, Occult bleeding, B. Breve
Major Genonmics Medical Research Center needs virology laboratory for anthrax and other testing on mammoth bone sample from Russia prior to doing DNA study on ancient DNA. Recent news, reported an anthrax outbreak in Siberia from carcasses underneath melted permafrost. The exact precedence of this sample in Russia its unknown, and we wouldn't like to take any risks regarding possible sample contamination.
We would thank you any help you could provide us with, regarding the testing and safety to use this material, Thanks very much cynthia
FDA GMP medical device laboratory needed for preclinical product safety testing: biocompatibility (10993) sensitization, cytotoxicity, irritation and and electrical(60601) testing for class II medical device with focus on FDA application. We need GPMS sensitization, cytotoxicity, muscosal irritation tests conducted. For 60601, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1 reports are needed.
Contract Research Organization needed for pharmaceutical clinical study on pre-exposure prophylaxis (PrEP) in drug users (n = ~400). PrEP involves taking a daily dose of antiretroviral medication, Truvada (Tenofovir/emtricitabine), to lower individual's chances of acquiring HIV. As one of our primary outcomes, we are measuring PrEP adherence over time. Based on our preliminary research and correspondences with our collaborators, we found 4 different measures to assess adherence to PrEP (Tenofovir/emtricitabine).
1. Peripheral blood mononuclear cells (PBMCs) 2. Dried blood spots (DBS) 3. Hair collection 4. Single plasma samples
We want to know which assessment method would be the most helpful and cost-effective for measuring Tenofovir and/or emtricitabine adherence.
Dental distribution company needs viral & bacterial (live/viable) analysis from wipe/swab samples. Analysis should include identification of specific type of virus (i.e. hepatitis, HIV, etc.). Samples will be obtained from hard surfaces, such as: dental equipment, tools, etc.
GLP Compliant Laboratory needed for ongoing testing of regenerative drug development (Cell Therapy Hellas) Test for: 1. HIV (anti-HIV (I/II), negative <1.0) 2. Human T-Lymphotropic virus I and II 3. Cytomegalovirus (antibodies for cytomegalovirus IgG, negative ,6.0 AU/ml; antibodies for cytomegalovirus IgM, negative 0.9 IV) 4. Epstein-Bar virus (antibodies for Epstein-Barr IgG, negative 0.19 AU/ml; antibodies for Epstein-Barr IgM, negative 0.19 AU/ml; antibodies EBV-NA IgG, negative <0.91) 5. Hepatitis C (antibodies for hepatitis C, negative <1.0) 6. HBV (HBsAg & anti-HBC)
FDA GMP Laboratory needed for FDA Nebulizer Aerosol Testing: to FDA 784 Guidance: 27 aerosol tests (1 nebulizer model, 1 flow rate, 3 sample devices [random samples], 3 drugs [albuterol sulfate, ipratropium bromide, cromolyn sodium]), 3 tests per sample per drug [3 samples x 3 drugs x 3 tests per sample per drug = 27 tests]. Cascade impactor run at continuous 28 l/min to simulate adult conditions. Predicate Nebulizer Testing: 9 aerosol tests (1 nebulizer model, 3 samples, 3 drugs [albuterol sulfate, ipratropium bromide, cromolyn sodium]), 1 test per sample per drug [1 model x 3 samples per model x 3 drugs = 9 tests]. Cascade impactor run at continuous 28 l/min. Testing report to include reporting on MMAD, GSD, Total Dose, Respirable Fraction (% 1-5 microns), Respirable Dose (ug 1-5 microns), Coarse Particle Dose ( > 4.7 microns), Fine
Contract Research Organization needed for Cardiology medical research studyto test an andotehelin receptor antagonist. Study includes the ability to conduct chronic cardiovascular surgery on large animals (pigs/sheep) .Test an endothelin receptor antagonist in an in vivo 21 day chronic experiment. A sterile infarct reperfusion injury study where anesthesized sheep have a coronary balloon catheter placed in a major coronary artery , inflated causing an ischemic episode , injection of an endothelin receptor antognist IV just prior to the release in this 1 hour ischemic period. Recover the animal for 21 days . Endpint would be planimetry and analysis of infarct size determination the left ventricle and extent of apoptosis in the heart muscle.
Clinical Research Laboratory needed for Food Nutritional Clinical Trials which will include plasma, serum, blood and DNA analysis for Changes in phosphorylation of mTor, AKT, Eif4E and rpS6 (muscle biopsy) Serum indices of skeletal muscle damage (creatine kinase and lactate dehydrogenase) Plasma insulin Blood glucose Plasma lactate Gene expression - mRNA expression of proteolytic markers Muscle glycogen Urinary indicators of protein breakdown (3-methyl-histidine and urea nitrogen)
URGENT TESTING Large Medical Device Company needs Microbiology laboratory for EP/USP Ethylene Oxide sterilization validation testing for 4 different products as per ISO 11737-2. Validate the Ethylene Oxide sterilization process, EP/USP including validation of test methods (B&F)
FDA cGMP pharmaceutical Laboratory needed for viscosity testing: Magnesium Aluminium silicate. Sample solution: After determining the Loss on Drying, weigh a quantity of Magnesium Aluminum Silicate, equivalent to 25.0 g on the dried basis. Over a period of a few seconds, transfer the undried test specimen to a suitable 1-L blender jar containing an amount of water, maintained at a temperature of 25 ± 2°, that is sufficient to produce a mixture weighing 500 g. Blend for 3 min, accurately timed, at 14,000?15,000 rpm (high speed). [Note?Heat generated during blending causes a temperature rise to above 30°.] Analysis: Transfer the contents of the blender to a 600-mL beaker, allow to stand for 5 min, and adjust, if necessary, to a temperature of 33 ± 3°. Using a suitable rotational viscometer equipped with a spindle as specified below, o
Regenerative Medicine Company needs FDA GMP or GMP compliant bioanalytical laboratory for characterization studies on the residual antibiotic (aminoglycoside) content of various tissue products under development.Previous successful work in validating analytical methods per USP Q2(R1) a must.
Clinical Laboratory needed for amino acid analysis: Plasma Amino acids by IEC and Organic acids by Gas Chromatography and Mass Spectrophotometry.Amino acids analyzer and GC-MS,5 %Sulphosalicylic acid,Amino acids standard solution,Amino acids control Level 1 & Level 2,0.4 micron filters and 3 ml Lithium heparin tubes.
EN 17025 accredited virology laboratory needed for disinfectant testing: Virucidal activity against Murine norovirus of alcohol-free, ready-to-use and concentrated surface disinfectants according to the European Standard; EN 14476:2013+A1:2015 Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of virucidal activity in the medical area. Test method and requirements (Phase 2/Step 1).
Contact times required: 1, 5, 30 and 60 minutes under clean conditions. Concentrations required: 100% (80% for concentrated product or 97% for ready-to-use product)
Medical Device Product Safety Laboratory needed for all biological testing for latex based medical devices with colorants needed for CE mark, FDA, ISO 13485 and Japanese biological safety requirements. Our products contact mucosal surfaces for weeks. May also need microbiology testing for sterilization.
Veterinary medicine laboratory needed for performance testing of diagnostic monitoring device that measures heart function, respiration rate, and continuous blood pressure against blood pressure machines (arterial catheters, doppler methods, and tail cuffs) for accuracy of values. It will need to be tested on both standing horses and horses under general anesthesia. Approximately 20-30 horses will need to be used.
Virology Laboratory needed for OPA (ortho-phthaladehyde) efficacy study on viruses Poliovirus type I, Rhinovirus type 42, Adenovirus type 2, Vaccinia (Wyeth), Coxsackievirus type B-3, Hepatitis A, Coronavirus, Cytomegalovirus, Influenza Virus (Hong Kong), Human Immunodeficiency Virus 1, Herpes Simplex-1, Herpes Simplex-2, Duck Hepatitis B, Avian Influenza A.
. Could you please quote us on these tests, exposure time to the OPA(which we will supply) is about 5 to 7 minutes? Please specify the cost per test too?
Preclinical laboratory needed for performing a number of in vitro studies using stromal vascular fraction (SVF) cells.These studies involve labeling of SVF cells with magnetic microparticles and superparamagnetic iron oxide nanoparticles (SPION).
We want to measure the following parameters:
1-Assess cell viability, self -renewal capacity and proliferation capacity. of SVF cells exposed to SPION. 2-Confirm the intracellular uptake of SPION by SVF cells using one or more of the available techniques to determine intracellular iron or SPION content per cell (colorimetric assays: Prussian blue assay, Ferrozine assay; ICP-MS; ferromagnetic resonance; magnetophoresis; MACS). 3- Assess the ability of cells to retain the label throughout several cell divisions (dilution effect).
I will be happy to share any additional informatio
Materials laboratory needed for surgical gowns testing - NFPA Standards - Standards for the use of Inhalation Anesthetics.
- ASTM 1670, Standard Test Method for Resistance of Protective Clothing Materials to Synthetic Blood.
- ASTM 1671 Test Method for Resistance of Protective Clothing Materials to Penetration by Bloodborne Pathogens Using Viral Penetration as a Test System.
- ANSI/AAMI PB70:2012, Liquid Barrier Perfrmance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
- ASTM F2407-06, Standard Specification for Surgical Gowns Intended for Use in HEalthcare Facilities.
- ASTM F1670-08/F1670M-08, Standard Tests Method for Resistance of Materials Used in Protective Clothing to penetration by synthetic blood.
- ASTM F1671/ F1671M -13, Standard Test Method for Resistance of
Bioanalytical Laboratory needed for cell viability (MTT), cell proliferation studies (flow cytometry to characterize CD) and self-renewal studies including tagging of stromal vacular factor (SVF) cells using superparamagnetic iron oxides (SPION) and characterize the tagging using colorimetric assays such as Prussian blue staining. In addition,cell viability, studies (MTT), self-renewal studies (flow cytometry to characterize CD) and cell proliferation studies are needed after the tagging has been performed.
Contract Research Organization needed for clinical research study: ELISA blood analysis for oxytocin on blood samples collected in hospital 3 times on 60 subjects.Analysis blood related to mood manipulation in voluntary participants (female). The sample is size 60 and the blood samples are collected in a hospital environment three times (180 samples). The oxytocin levels need to be measured with ELISA (Enzyme-linked Immunosorbent Assay Kit) kit.
Laboratory needed for transportation test for the new packaging box according to ASTM D4169-09 as per below: Please help to quote the test as below, Distribution Cycle 13, Assurance Level III. Test sequence as below: 1. Temperature and Humidity Conditioning 2. Schedule A: Handling 3. Schedule C: Vehicle Stacking 4. Schedule F: Loose-load vibration 5. Schedule I: Low Pressure 6. Schedule E: Vehicle Vibration 7. Schedule J: Concentrated Impact 8. Schedule A: Handling
Medical Device Company needs medical technology laboratory for packaging/ product /development of developing a disposable medical cable assembly that will require sterilization. ABS plastic housing for connectors Silicone vs PVC for cable assembly I have questions about cost, materials, packaging and logistics.
Scientific researcher would like bioanalytical laboratory for research study using measures of salivary cortisol and oxytocin. Need budget for purposed of preparing a grant proposal, and need urgent information regarding the costs implicated for the collection material, assays, and lab analyses work.
URGENT Research Scientist needs genetics laboratory for SNP studies, DNa isolation , PCR amplification and sequencing studies for FADS gene polymorphism in diabetes. 200 samples
LONG-TERM TESTING Genetics Laboratory needed for DNA sequence replacement. We have our own BAC that we would like to make 6 sequence replacements in. All but one are less than 200 bp and one is 13kb. We can provide the DNA sequences necessary for recombination. Can you provide a quote on a per replacement basis as well as for a set of 6 sequence replacements simultaneously? (We plan to make one big initial set of changes and then will do single changes a few times per month thereafter)
We think two step recombination is required since we want exact changes made (step 1 - insert a selection cassette at the change site and step 2 replace the selection marker with our custom DNA insert)
We are not picky about the destination vector - we have used EPI300
Medical Device Microbiology Laboratory needed for disinfection and cleaning efficacy testing for needleless IV connector. to ASTM-E-1837 Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test) AND/OR ASTM-E-2314 Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test) needs to be performed. 6 cases need to performed in triplicate for each standard. The device being evaluated is a needleless IV connector.
Very Experienced, FDA certified Preclinical Contract Research Organization needed for in vivo preclinical studies for 2 phase subset of FDA biocompatibility testing of eye implants in rabbits (eye implants intended to be used for cataract surgery in human). The program includes: - intramuscular or subcutaneous implantation test for 4 weeks - 6 test and 6 control rabbit eyes minimum 6 test months We would need the full set of services including preparation of the detailed study plan according to the ISO standards (ISO 11979-5), performing testing in animals and preparation of the final study plan including statistics.Please specify preliminary pricing offer for the services?
Mechanical Laboratory needed for ISO mechanical testing to ISO 594 Testing of Conical Luer Fittings
1. Luer Assembly: Ensures that the Luer specimen can be assembled with minimum axial force and torque.
2. Separation Force: Ensures that the Luer specimen remains attached to the reference fitting when an axial load is applied.
3. Unscrewing Torque: Ensures that the specimen Luer remains attached under a specific unscrewing torque in the counterclockwise direction.
4. Resistance to Overriding: Ensures that the threads cannot be overridden by a specific screwing torque in the assembly clockwise direction.
Electrical Laboratory needed for Diagnostic Medical X-Ray equipment testing: Insulation Resistance test before & after Humidity condition as per BIS norms (IS 7620-1986) we are giving below the details of the tests to be carried out. 1) Humidity Test (IS 302-1979) Humidity >= 95% at 35 to 45 Deg. centigrade for 48 Hrs followed by following test. 2) Insulation Resistance Test (IS 7620-1986,6.2.1) Apply 500 VDC for 1 Minute. Insulation Resistance >=2M ohm
Clinical Sports Performance laboratory needed for clinical biomechanical testing in humans to validate performance of university's sports biomechanics equipment Simi motion analysis system, Vertigo static and dynamic balance system, Bertec force platform, Myon EMG, IsoMed 2000-dynamometer.
Laboratory needed for development of companion animal lateral flow antibody and antigen diagnostic test products including Canine Heartworm, Lyme disease, Ehrlichia canis, Anaplasmosis and in the feline, FeLV and FI .Need USDA required testing for sensitivity, specificity and inter-laboratory validations with securing US source reagents (whole blood, plasma, and serum) In most cases the assays are detecting antibody. In a small number of cases we will be detecting antigen.
Materials Laboratory needed for biomechanical / biophysical testing for medical device burs: ¬Mechanical force of d¬evices test (compress¬ion, Torsion) Biomechanical property of dental burs is important for safety usage so test should assure torsional yield strength, torque, breaking point of dental burs moreover determine compression load force of device on rigid test block. Test apparatus should be arranged for axial force. 5.¬ ¬? compression and fat¬igue test and standar¬ds Fatigue test is especially for multi-use burrs, So company should proves that performance of product does not change after pre-determined numbers of multi- usage.
Medical Device Manufacturer needs medical device laboratory for sterilization validation of device sterilization process. 1.¬ ¬Sterilization method: ¬ We will supply instr¬uctions for a method ¬with step by step ins-tructions and we need¬ to get the steriliza¬tion validation ? the¬y will be autoclaved Yes it is correct but you should validate your steam sterilization parameters, temperature,duration,pressure etc. After you sterilize your products according to your set values. you confirm with sterility test that No Microbial Contamination on products. Cleaning and Sterilization Instructions Spring FG Diamond Burs are non-STERILE, but should be cleaned and sterilized before use and subsequent reuse. .
Ultrasonic Cleaning Procedure Prepare a fresh pH-neutral cleaning solution; place the Diamond Bur in the dedicated instrum
FDA GMP Bioanalytical Laboratory needed for blood testing for platelet yield , %platelet recovery and platelet recovery factor in PRP tubes for obtaining autologus plasma . Use of hematology analyzer to quantify the platelets contained within start sample and platelet concentrate
FDA GLP Pharmaceutical laboratory needed for Active Pharmaceutical Ingredient Testing: Analysis of APIs using test methods: 1) Elemental composition (CHNO) 2) 1H NMR 3) 13C NMR 4) Differential scanning calorimetry (DSC) 5) Thermogravimetric analysis (TGA) 6) X-Ray structure analysis
Toxicology Laboratory needed for toxicity tests and eco-toxicity testing of new molecule used in a Medical Disinfectant for new surfaces. These tests we need to be able to write up a safety data sheet. including: 1) Ecotest Daphia, 2) Ecotest Pseudokirchneriella, 3) Skin irritation, 4) Eye Irritation, 5) Skin Corrosion.
Contract Medical Device Laboratory needed for FDA Testing of endotracheal tubes (ETT) to FDA recognized standards.
? ISO 5356-1 (2015), Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets ? AAMI ANSI ISO 5361 (2012), Anaesthetic and respiratory equipment Tracheal tubes and connectors
Bioanalytical Laboratory needed for Product development work for molecular biology (PCR, library prep, DNA sequencing on Illumina platform). We need help with verification testing using a molecular laboratory. Must follow protocols and generate data for reports to be submitted to FDA as part of design control.
Preclinical laboratory needed for gene enhanced cell therapy toxicology study in immunocompromised rats, cannulated jugular vein injection of gene enhanced cell therapy product. Standard 8 week toxicology study in 20 athmyic nude rats -Deadline for report is November, require start date of mid-august
FDA GMP Medical Device Laboratory needed for biocompatibility testing of polypropylene mesh for medical use for a 510(k) application in accordance with the Blue Book Guidance G95-1, (Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing), acceptable test results should be supplied for the biological tests listed below. Standard protocols such as those identified by the USP or ASTM should be used in conducting the biocompatibility testing, if possible. Such tests should be performed on devices ready for surgical use (i.e., after manufacture, sterilization and packaging for commercial distribution). Cytotoxicity Sensitization Irritation or Intracutaneous reactivity Systemic toxicity (acute) Genotoxicity Implantation (with histology of the surrounding tissue) Hemolysis Pyrog
Packaging laboratory needed for ASTM transportation testing for the new medical device packaging box according to ASTM D4169-09 as per below: Please help to quote the test as below, Distribution Cycle 13, Assurance Level III. Test sequence as below: 1. Temperature and Humidity Conditioning 2. Schedule A: Handling 3. Schedule C: Vehicle Stacking 4. Schedule F: Loose-load vibration 5. Schedule I: Low Pressure 6. Schedule E: Vehicle Vibration 7. Schedule J: Concentrated Impact 8. Schedule A: Handling
Preclinical Contract Research Organization needed for multiplex assays or proteomic studies for toxicity study on therapeutic treatment for Muscular Dystrophy. The study involves determination of kidney and liver toxicity in mouse samples (i.e. serum and urine). Our aim is to determine whether we can detect kidney and liver toxicity biomarkers in mice which have been chronically treated with these oligos at various doses. If we can successfully detect elevated biomarkers then this will help determine the therapeutic window of the drug, which will greatly assist in screening for safer and more effective treatment.
Research Scientist needs bioanalytical laboratory for plasma testing of 150 human plasma samples. Bioanalyis for creatinine, thiosulfate, and homocysteine using a method of conjugation of monobromobimane to thiol groups for fluorescence detection. Testing needs to be outsourced while our HPLC is waiting to be fixed. Please let me know if laboratory is capable of fluorescence detection with HPLC as well as what other information is needed for a quote.
Biomaterials laboratory needed for in-vitro surgical sealant testing 1. Burst test of surgical sealant (2-PEGs) as per ASTM F2392. 2. Gel Time test - surgical sealant (2-PEGs) 3. Swell Test - surgical sealant (2-PEGs) 5. Gel Mixing test - surgical sealant (2-PEGs)
Pharmaceutical laboratory needed for comparison studies: efficacy testing of chemically-modified the structure of known pharmaceuticals that can test and measure the pharmaceutical efficacy of the modified structure of the compound, and compare it to the non-modified, original pharmaceutical. The first step would be to compare the medical efficacy of the new compound to the original pharmaceutical need a NDA signed by both parties. Please specify a ballpark figure on cost to perform the first stage of the efficacy test. We are looking forward to your reply and comments.
LONG-TERM: Preclinical CRO Immunology/Histology Laboratory needed for Non-GLP histological processing from buffered formalin fixed tissues (human and animal, size 6 mm diameter, approx. 40 um thick) into H&E stained slides (at 3 different levels) and about 10 FFPE unstained slides for further subsequent immunohistochemistry,
New clinical business needs Clinical diagnostic laboratory for clinical testing of it's samples (approx 1200/month) including testing such as CBC, all hormone teting, chemistry panels,lipid panel, heart panel. Pap smear testing, thyroid testing, allergy testing, diabetes panel, DNA referrals. In other words all Non DOT testing.
FDA Electrical medical device laboratory needed for Skin massager testing: 2. FDA Product Code : PBX 3. Performance test standard ? IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance. ? IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility ? Requirements And Tests. ? IEC 60601-2-2: Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories. ? IEC 60601-2-57: Particular Requirements For The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosme
ILAC certified laboratory needed to perform testing of instruments and systems against IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests and ISO 14457:2012, Dentistry Handpieces and motors
Medical Device CE Mark microbiology certification laboratory needed for CE certification testing of opthalmology multi purpose contact lens solution. CE require the following three new tests for multi purpose solution. 1) Antimicrobial activity test in accordance with ISO 14729. 2) Compatibility test between contact lens care products and contact lenses performed according to ISO11981 3) Preservative efficacy test according to ISO14730 Please specify the estimated price and testing time for each tests if that is available
Genetics Bioanalytical laboratory needed to perform microarray experiment for miRNAs, using Custom Tagman Array MicroRNA Cards, format 24 (23 miRNAs, 8 samples with 2 replication/sample) to test a very low amount of total RNA (about 10 ng), so a pre-amplification will be necessary in this case. Please provide a quote for 80 samples, including pre-amplification and running the microarray? Please specify the estimated time from receiving the samples at your end until we get the data.
LONG-TERM TESTING Clinical Central Laboratory processing blood and plasma needed for product development and optimization studies microfluidic devices and their components to study the effect or interference of devices on blood chemistry and overall specimen integrity.
Initially, we would like to send a few samples (n=10) for a complete blood count (CBC) and comprehensive metabolic panel (CMP) to determine baseline values. After we have identified any significant differences in samples exposed to a variety of conditions, we would be interested in continued testing by your company for optimization of our products. There would be no chemicals, drugs, or hazardous substances in contact with the specimen at any time? just inert molded plastics and rubber.
Please specify t cost may be associated with these types of analyses.
Medical Devices manufacturers of surgical instruments and implants in India needs microbiology laboratory of disinfectant viral efficacy testing of Natural and Organic Disinfectant for various applications and uses.
The active ingredient of this product is Citrus Aurantium amara extract in the form of Bioflavonoid complex, also commonly known as Bitter Orange extract classified under the CAS No. 72968-50-4.
We are quite sure that this product would help the society and the Population at large in preventing or controlling the spread / outbreak of any viral epidemic in the future.
I request your goodselves to kindly provide me a lab contact, to discuss further.
Thanking you and looking forward to receive your early communication in this regard.
With best regards, For General Surgical Company India Pvt Ltd,
Laboratory Consultant needs Medical urine testing (red and white blood cells) for pain mgmt.
Medical device company needs GLP laboratory for quality control of Ophthalmic viscosurgical devices, according to ISO 15798:2013, Ophthalmic implants Ophthalmic viscosurgical devices
Required tests: concentration, molecular mass distribution, shear viscosity, elasticity, pH, chemical and biological contaminants (heavy metals, proteins, nucleic acids, residual IPA), osmolality, spectral transmittance, particulates, refractive index, bacterial endotoxins test, sterility test, Hemolytic streptococcus hemolytic test
Medical Device Product Safety Laboratory needed for Stability Testing and Biodegradability Testing of Nature latex foley balloon catheter ,Scalp vein sets, feeding tube (PVC) ,and other surgical disposable product to ISO 10993, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process. send test quotation
US Microbiology laboratory needed for comparison study of two different antimicrobial agents using a time kill study. Microorganisms to be studied are Pseudomonas aeruginosa, Staphylococcus aureus, and Aspergillus niger. I want testing at 3 time points, 1 min, 3min, and10 minutes.
Medical Institute needs India Bioanalytical Laboratory for protein analyssis: disulfide bridge mapping of protein. Please specify cost.
Clinical diagnostic laboratory needed that provides mail-in STD Testing services for blood, swabs and urine samples for:
1. Chlamydia 2. Gonorrhea 3. Hepatitis C 4. HIV 1 & 2 5. Trichomoniasis 6. Herpes Simplex 1 7. Herpes Simplex 2 8. Syphilis 9. Hepatitis B 10. Hepatitis C 11. Gardnerella Vaginalis (Bacterial Vaginosis) 12. Mycoplasma Genitalium
Medical Device Company needs Medical product safety laboratory accepting quotes for conducting biocompatibility testing of a (laminated) fabric sample to ISO Standards used in medical device: Cytotoxicity ? ISO 10993-5 Sensitization ? ISO 10993-10 Irritation/Intracutaneous ? ISO 10993-10
Thanks in advance.
Opthalmic Medical Device Company needs Europe or USA Laboratory for determination of cyanide level on a medical device (electrode)
Medical devices manufacturer of FDA class I,Ila and III medical devices needs India NABL laboratory for biocompatiability studies
Microbiology Laboratory needed to Identify Fungi & Bacteria in 1/2 ounce specimen Jars Some in water others dry Please provide cost
Medical Device company needs laboratory for staining with Toluidine-blue on our samples (hydrogels) and pictures (5x, 10x and 50x) magnification.
Medical Technology laboratory needed for medical device testing to 60601-1 Medical electrical equipment?Part 1: General requirements for basic safety and essential performance
60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Virology Laboratory needed for performance testing of an ultraviolet germicidal irradiation (UVGI) device used to kill H1N1 influenza virus deposited on respirator coupons. Experiments needed to evaluate the performance of the device using other viruses. We are requesting a quote to evaluate the performance of the device using the following viruses: H5N1 (low path); H7N9 (low path); H5N9; SARS; and MERS-CoV. We will provide the UVGI source and provide training on the method.
Medical Clinic needs clinical diagnostic laboratory for surrogate patient OBGYN lab testing
Medical Device manufacturer needs FDA GMP Product Safety Laboratory for Toxicology Testing to support FDA 510K application
a) A comprehensive scientific justification for the use of a additive containing heavy metals in a medical device b) Extractables and Leachables Testing on the final finished device, using an exhaustive extraction at 50oC for 72 hours in both a nonpolar and polar solvent c) A dermal risk assessment for each chemical extract characterized in the solvents following the Extractables and Leachables Testing
Pls comment on your proposal
France University researcher needs histology laboratory for Immunohistochemistry on 1 slide (TMA) for research antibodies (already purchased or not, examples ALDH, SOX).
France university needs Histology Laboratory needed for Immunohistochemistry for anti-mitochondria antibody: send slide with tissue section (formalin fixed, paraffin embedded specimen).
Biophysical Laboratory needed for ISO Testing of medical implant. The material is Metal. It is to ensure that the design does not fail under standardized conditions for example ISO 9585:1990, Implants for surgery Determination of bending strength and stiffness of bone plates
Midwest USA High complexity CLIA lab to perform LC/MS/MS urine drug testing on 1200 samples.
India microbiology laboratory needed for fungus testing of some fungus developing on the walls of medical facility.
Medical Device company needs biomedical laboratory to provide a quote for CLSI EP07 Interference Testing in Clinical Chemistry on with Neisseria gonorrhoeae and Chlamydia trachomatis.
Southern USA high-complexity toxicology laboratory needed for to process toxicology samples from 3 different treatment centers. Approximately, 500-1000 samples a month.
Microbiology laboratory needed for medical fabric testing for bacteria-resistance. It is nylon taffeta 70 denier with a pic waterproof backing. The same material used for mattress liners in hospital and nursing home settings. I m looking to getting more information s to what types of testing you would do, what certificates can be granted, and an estimate to the cost for these services.
University researcher needs India biomechanical laboratory for bone testing: 1) porosity 2) Mechanical test like compression and tensile.
US Microbiology Laboratory needed for EN ISO Microbial Analysis to EN ISO 22612 Dry Micobial Penetration test
Analytical Chemistry Laboratory needed for LC-MS data analysis from Toxicology screenng a
India Microbiology Laboratory with ISO/IEC 17025 NABL Accredition needed for bioburden testing, bacteriostasis and fungistasis testing
Doctorate Medical Researcher need bioanalytical laboratory for experimental procedure: The requirement to get rat hippocampus microdialysis samples analyzed for glutamate and GABA by HPLC using the same method used in the attached publication of our lab (we have 120 samples that need to be analyzed). The experimental procedure is essentially the same as in the attached publication. Please the cost of the per samples analysis.
Gastroenterology Preclinical Product Safety Contract Research Organization (CRO) needed for weight loss study with capsule inserted in the stomachs of 6 genetically obese mice and then have mice observed for weight loss.
Eye wear company imports eyeglass frames from Italy and would like FDA GMP laboratory for certification testing that frames are made from FDA approved raw materials.
Medical Device Company needs laboratory to provide quote for testing of DEHP, Latex and Phthalates on catheter. Catheter is composed from various materials: Gray Pellethane - proximal hub, Yellow - pellethane - body, Air valves - PVC, Blue & yellow Pebax - distal end, Grey Pebax - distal hub.
Third-Party Laboratory needed for shoe testing to American Podiatric Medical Association's Seal of Acceptance for children's shoe lines. The APMA requires that we submit our shoes to third-party lab tests to establish the product?s safety (including a Material Safety Data Sheet and EPA/FDA approval documents where applicable), as well as other health-related properties, such as the product being lightweight, very flexible, and slip-resistant.
Medical Device Company needs laboratory for Particle count testing in accordance with clause 14.2 of EN 45502-1:1997, Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer.
Microbiology laboratory needed for pyrogen testing for a medical device and components. the active ingredient is photosensitive and testing under yellow lighting would be required. None of the materials used in the device have radioactive properties
Life Sciences Company developing medical treatments needs Industrial Hygiene Laboratory for environmental monitoring testing 1. Environmental monitoring is being performed on February 8, 9, and 10 - Sampling is performed using a viable particle counter and TSB plates - We will need to have plates picked up on each day at 15:00-16:00 - There will be approximately 50 plates for each day 2. Other contract labs we have worked with used the following method to read plates. Please specify your method of reading? - Incubate plates at 35C for 3 days - Check plates for growth or no-growth - Plates with growth will have micro-organisms identified - Plates will be held for an additional 7 days for fungus. If growth occurred, then they will be identified 3. No MRSA or VRE testing is required
Contract Laboratory needed for mosquito repellent testing to ASTM International. E 951-94. Standard Test Method for Laboratory Testing of Non-Commercial Mosquito Repellent Formulations On the Skin. (reconfirmed in 2000) ASTM International. E 939-94. Standard Test Method of Field Testing Topical Applications of Compounds as Repellents for Medically Important and Pest Arthropods (Includind Insects, Ticks and Mites): I Mosquitoes (reconfirmed in 2000)
Bioanalytical laboratory needed for bioanalysis on Stromal Vascular Fraction cells isolated from adipose tissue including Residual collagenase activity (colorimetric assay kit available) Bioanalytical laboratory needed for Flow cytometry (CD31/Cd34/CD45) Endotoxin testing Colony forming unit- fibroblast (CFU-F) assay
LONG-TERM ONGOING: UK or Denmark GLP Laboratory needed to obtain a quantitative determination of the following components : ? Dipalmiotylphosphatidylcholine (PC16:0/16:0) ? Total Sphingomyelin (SMtotal) ? Total Phosphatidylcholine (PCtotal) ? Total Phosphatidylglycerol (PGtotal) ? Phosphatidylinositol (PItotal) We prefer to use the concentration unit of nmol/ml, and expect that the components are present in the following concentration ranges : ? PC16:0/16:0?0,5 - 150 ?nmol/ml ? SMtotal?0,1 - 40 ?nmol/ml ? PCtotal?1.0 - 500?nmol/ml ? PGtotal?0,3 - 50?nmol/ml ? PItotal??2 - 30 ?nmol/ml
Eastern Europe medical device laboratory needed for Personal Lubricant Ge testing. Two tests; 1) Condom compatibility test 2) Spermicid Test (Our product does not kill or kill sperm)
Microbiology Laboratory needed for microbial testing of manufactured medical device parts for specific microbiological requirements. We are a contract plastic manufacturing company for medical products and have a specific test requirements. for
TAMC (Total Aerobic Microbial Count) -9999 0 200 cfu/gm STM-00412, STM-00411 Note 1 TYMC (Total Yeast & Mold Count) -9999 0 20 cfu/gm STM-00412, STM-00411 Note 1
Preclinical Laboratory needed for in-vivo gastroenterology study to get a first estimation of the likelihood that a gastroenterology physical barrier might become twisted or entangled in some fashion that it could cause harm to the animal and my inference to any future human trials. Another objective is to identify any undesirable elements associated with food waste that has not had its nutrients removed in a normal manner.Need to have specially sized condom like sleeves emplaced in the stomachs of 6, genetically obese lab rats and then have their diets, weights, and stools monitored for two months. These condom like sleeves will be encapsulated in gelatin capsules. Once emplaced in the rat stomachs, they are expected to assume a round diameter two large to pass into the rat intestines. As food is pushed into the intestines, this condom l
Universitry Researcher needs clinical diagnostic laboratory for blood testing for Palladium toxicity in patient.
Medical Device Laboratory needed for EUropean Pharmacopeia Testing of Surgical threads to European Pharmacopeia [8.0] Monograph 01:2008:0324, IDENTIFICATION For (Silk sutures) Identification of silk: A. Dissect the end of a suture, using a needle or fine tweezers, to isolate a few individual fibres. The fibres are sometimes marked with very fine longitudinal striations parallel to the axis of the suture. Examined under a microscope, a cross-section is more or less triangular to semi-circular, with rounded edges and without a lumen. B. Impregnate isolated fibres with iodinated potassium iodide solution R. The fibres are coloured pale yellow. For UNILIN (Linen Sutures). Identification of linen A. Dissect the end of a suture, using a needle or fine tweezers, to isolate a few individual fibres. Examined under a microscope, the fibres are se
ISO 17025 accredited Medical Device Laboratory needed for ASTM Testing of Hernia Mesh - 3 types (Flexpro mesh, Polyester mesh, polypropylene mesh) ? Cotton Umbilical Tape. Tests required. 1. Stiffness Test as per ASTM-D1388-14. Test may be conducted with option-1: Cantilever or option-2: Heart Loop 2. Bursting Strength of Textiles - Constant-Rate-of-Traverse (CRT) Ball Burst Test as per ASTM-D3787-15 3. Breaking Strength and Elongation as per ASTM-6775-13 Please make sure your office is ISO 17025 accredited
Medical Device Laboratory needed for ISO Compliance testing on Temporary Cardiac packing wire & Stainless steel wire). 1. Compliance verification report for Temporary Cardiac Pacing Wire as per EN 60601-1:2006/A1:2013, EN 60601-1-2:2007/AC:2010, EN 60601-1-6:2010 2. Chemical Composition Test Report for Temporary Cardiac Pacing Wire as per BS ISO 5832-1:2007 3. Mechanical Properties Test Report for Temporary Cardiac Pacing Wire as per ISO 10334:1994 4. Chemical Composition Test Report for Stainless steel wire as per BS ISO 5832-1:2007 5. Chemical Composition Test Report for NEEDLE as per ISO 7153-1:1991 & ISO 13402:1995
URGENT: USA FDA GMP Medical device laboratory needed for device functionality and performance testing of medial devices used to administer biological drugs intra-parentally to humans. These devices include auto-injectors, pre-filled syringes, etc. Testing includes break loose/glide force testing, flow testing, simulating transportation and drop testing, etc.
San Diego California Blood Laboratory needed for blood testing: Peripheral blood Karyotype molecular
EPA laboratory needed for ISO 10993 and/or The Ex Vivo Porcine Skin Test. testing of a device that converts an aqueous saline solution into a cleaning & disinfecting solution by electrolysis. We would like to make a claim indicating that at 200 ppm FAC and 400 ppm FAC the resulting solution is harmless to skin and other human and animal tissue including eyes. We believe that to make these claims the EPA requires that we publish results of ISO 10993 and/or The Ex Vivo Porcine Skin Test.
We would like to be contacted by an EPA approved lab capable of performing these tests.
CALIFORNIA OR TEXAS FDA GMP MICROBIOLOGY LABORATORY NEEDED FOR STERILIZATION VALIDATION TESTING OF ETO STERILIZED CONSUMER BANDAGES . 4 products one full container
large medical device manufacturer needs FDA GMP toxicology laboratory for toxicology testing: Modified draize-95 test to meet FDA requirement
Biomedical Laboratory needed with MRI Suite for MR headset testing. To be tested for attenuation and chamber noise test. anutation test and any sort of chamber testing along with applicable 510k Testing like RF heat
FDA GMP Biomedical laboratory needed for FDA testing of personal lubricants for 510k submissions Condom compatibility testing.
Medical Device Manufacturer needs laboratory for disposable gown and drape testing to Association for the Advancement of Medical Instrumentation AAMI level of disposable Gown and Drape, we need to test AATCC 42, AATCC 127, ASTM F1671, ASTM F1670
Preclinical Laboratory needed for Biocompatibility Study for implant material SS 316L as per ISO 10993 , Biological evaluation of medical devices
Biomechanical Laboratory needed for mechanical testing of orthopedic implants for CE/ FDA certification
Medical Device Product Safety Laboratory needed for Stability Testing and Biodegradability Testing of Nature latex foley balloon catheter ,Scalp vein sets, feeding tube (PVC) ,and other surgical disposable product to ISO 10993, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process 1.In vitro cytotoxicity test 1.3test on extract 3.Irritation test 3.animal Irritation test 5.Sensitization test 5.2 maximization method- guinea pig 8. Implantation test 8.1 subcutaneous Tissue 8.1.1 short term (4 week to 12week) please send us quotation
Medical Device Manufactrer needs Biomedical Contract Laboratory to generate a pressure map of a device pressed against a surface (to simulate skin contact). We'd like to have a 2D heat map of the pressure exerted on the surface. I've seen a film that may be suited to this, but am open to alternate options.The resolution needs to be high enough to accommodate millimeter scale differences.
Microbiology laboratory needed for assays for studying zone of inhibition of anti-H. pylori activity. Please provide quotation
Organizaiton needs Microbiology Laboratory for MIC testing: MICs for the different kind of antimicrobials used in clinical practices for a Acinetobacter environmental strain (not a multidrug-resistant strain).
Medical Device Laboratory needed to perform a test that will measure the volume (or amount) of a gas which flows out from a bag made of silicone rubber. the bag is under pressure and i need to know how much gas got out of the bag in specific time.
SAMPLE PREPARATION: Large medical device company needs laboratory to prepare samples: Polish/grind circular disc that are 15±1 mm in diameter and 1.4±1 mm thick. Grind each specimen through diamond-embedded media having a nominal grit size of 30 ?m to 40 ?m and final polish on media having 15 ?m to 20 ?m diamond grit.
Pennsylvania, New Jersey or Maryland Medical Device Laboratory needed for Product safety and efficacy testing for nasal strips Scientific research for Efficacy to gaining insight on percentage of nasal airflow variances
USA FDA GMP BIomedical laboratory needed for FDA medical suture evaluation of 8 suture samples
Ireland bioanalytical laboratory needed to test the hemocompatibility and coagulation times of human blood in a needle . to investigate different surface treatments to increase the coagulation times of blood within the needle lumen.
Medical Device Safety Laboratory needed for amazon safety testing Polypropelene Homopolymer contact lens case to sell on Amazon. Product testing document OR safety assessment document, whichever is the easiest and least expensive to obtain.
Consumer Product Safety Laboratory needed for Drop Ball testing of Class 1 Medical Device - Sunglasses. Testing of 500 units
Biochemistry laboratory needed for calibration of the sensitivities of immunoassay tests. We calibrate the sensitivities of the immunoassays using calibrators. We are interested in a lab who can assay controls for us to know the quantitative value of certain analytes in the control At the moment, we are interested to assay Drug of Abuse calibrators using HPLC or Gas Chromatography method. We are also interested to assay an hCG hormone calibrator. We will provide the calibrators. HPLC/Gas chromatography testing of Drugs of Abuse controls.
ISO 17025 or FDA GLP Accredited Test institute needed for catheter and catheter accessory biocompatiability testing of these materials according to related standards to Test Standard: 10993-1. We will focus on products which will stay more than 30 days in body. 2. nd product: Implantable Gel material Please give me price and make me informed about the procedure and accreditation status
USA genetics laboratory needed for Genetic Sequencing for Illumina testing- pediatric inherited disease panel and autism panel
UK MHRA Bioanalytical laboratory needed for verification testing for justification of the use of 263 hamster adapted strain of scrapie agent for viral inactivation testing of bovine collagen hemostatic medical device in 2014 rather than the 301V mouse strain of BSE agent believed to be more predictive. They want us to justify the use of 263k and why it is still adequate. We are looking for an expert laboratory to write us a justification memo of the strain 263k is still a good method to use. Is this something your laboratory could help us with and quote?
Bioanalytical laboratory needed for bioavailability testing for Stability testing on transdermal vitamin B12 patch for 3 year shelf-life
Medical Device Laboratory needed for Bioavailability and Stability testing on transdermal vitamin B12 patch. We have a list of protocols to follow for this test, but essentially need to confirm bioavailability of ingredients for 3 year shelf life.
United States consumer product safety laboratory needed for consumer product safety testing document or safety assessment for amazon.com for a marketed medical food product
USA biomedical laboratory needed measure the volume displacement over time of a self inflating device. Need a high level of accuracy because of the small size of the device
USA biomedical product safety laboratory needed for Medical Device Directive Bio-compatibility and Microbiological Safety testing performed on our Temporary Crown and Bridge Material for compliance to Medical Device Directive 93/42/EEC EN ISO 10093-1 EN ISO 11737-1:2006
Biomedical laboratory needed for measurement of drug elution rate from coronary stents
Southeast preferred United States laboratory needed for ASTM Lead Equivalency and Attenuation testing per ASTM F2547-06 standard lead free material tested for Pb equivalency and attenuation at 60kvp, 80 kvp, 90kvp, and 100kvp
Medical Device product safety laboratory needed for Amazon Healthcare product safety testing performed on a very heating pad I'm selling on Amazon. In order to be listed in the Health Care category, I need certification that safety testing has been performed by a lab.
This product is literally a cotton bag filled with flax seed and scented oil - about as simple as it gets. It is made by hand in the USA.
I'm interested in understanding how much it would cost to have this product tested and what you need in order to complete such testing. I'd also like to confirm that testing performed by your organization will be considered sufficient & acceptable by Amazon as they assess my product in the "Health Care" category.
Thanks for your time and attention.
INDIVIDUAL Texas area clinical laboratory needed for blood testing for biomarkers of Hep C treatment drugs when combined with Prozac and other prescribed drugs after death.
COnsumer Products Safety Laboratory needed for safety assessemnt to Amazon seller requirement: product testing document OR safety assessment document. My product is made of polypropylene (PP) and touches only the contact lens case, not the lenses themselves.
East Coast USA microbiology laboratory needed for disinfecting device disinfectant efficacy testing. $20,000 as a subcontract for the efficacy testing during Phase I. If you are interested please let me know and I can send you the NDA to sign before I can send you the details,
Toxicology Laboratory needed for toxicology testing of agricultural fungicide: Toxicological data on the technical grade material (Animal data) 1. Acute oral toxicity 2. Acute dermal toxicity 3. Inhalation toxicity 4. Skin irritation 5. Eye irritation 6. Skin or dermal sensitization 7. Sub-acute studies 8. Teratology/reproductive studies 9. Mutagenicity studies 10. Toxicity on nervous system studies 11. Metabolism data required to determine of absorption, excretion, distribution, accumulation and transformation in the animal body and their metabolites. 12. Tumor and cancer induction (if any) Toxicological data on the formulated/finished product (Animal data) 1. Acute oral toxicity 2. Acute dermal toxicity 3. Inhalation toxicity 4. Skin irritation 5. Eye irritation 6. Skin or dermal sensitization 7. Precaution for usa
Asia biomedical laboratory needed for FDA 510k opthalmic shunt testing : Aqueous Shunt Gravity Flow Test: to evaluate the pressure/flow characteristics of an aqueous shunt when exposed to a decreasing pressure gradient in an aqueous environment. The experimental data obtained from this test may be used to calculate a theoretical resistance to flow for the aqueous shunt. Constant Flow Test: to evaluate the pressure/flow characteristics of an aqueous shunt when exposed to a constant flow rate (mimicking physiological flow rates) in an aqueous environment. The experimental data obtained from this test may be used to calculate a theoretical resistance to flow for the aqueous shunt.
California Materials laboratory needed for ASTM rheology Testing to determine levels of cure in samples of liquid silicone rubber to ASTM D6601-12, Standard Test Method for Rubber Properties?Measurement of Cure and After-Cure Dynamic Properties Using a Rotorless Shear Rheometer
Clinical genetics laboratory needed for Next generation and microarray analysis of blastomeres
Karachi India bioanalytical laboratory needed for ELISA Testing on saliva for research
Texas Laboratory needed for ISO Comparative testing for contact lens solutions to ISO 11981 2nd ed 2009 Ophthalmic optics Contact lenses and contact lens care products Determination of physical compatibility of contact lens care products with contact lenses
ISO 11986 2nd Ed 2010 Ophthalmic optics Contact lenses and contact lens care products Guidelines for determination of preservation uptake and release
Toxicology laboratory needed for cytotoxicity testing of PVC Films used in the medical industry. I?m also interested in quotes for USDA class 6 testing.
India dentistry laboratory needed to check erosion on natural teeth using dental wet wear abrasion tester.
Large Medical Device Manufacturer needs materials laboratory for Haze and transmittance testing on a flexible polymer Sample size < 20
University Medical Researcher needs clinical laboratory with ability to run HPLC on stool samples to test for type/amounts of short chain fatty acids and metabolites in the samples (butyrate, propionate, etc.) for medical research project.
West Coast USA Biomedical Laboratory needed for compression testing on 3m mesh leg wrap.
Medical Device Laboratory needed for USP Testing of sutures to USP 861: Suture- Diameter USP 871: Suture- Needle Attachment USP 881 : Surgical Suture- Tensile Strength
Medical Device Materials Laboratory needed for ASTM Condom Testing to ASTM D7661 - 10 Condom Compatibility Test
Physical Laboratory needed for medical device vibration testing and physical impact testing of Titanium Osmotic Pump in Medical Devices
US Analytical Chemistry Laboratory needed for USP Testing to Test triclosan powder for 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) and 2,3,7,8-tetrachlorodibenzofuran (TCDF) per USP<38>.
US Non-GLP Medical Device Contract Research Organization CRO needed for non-GLP broncoconstriction study of implantable neurostimulator.
FDA Plastics and Polymer Laboratory needed for ASTM Testing of Polypropylene (FDA-CFR-177.1520) Test: Density (ASTM method D1505?68); Melting point (ASTM method D2117?82); Hexane Extractables; Xylene Extractables Material: Polyethersulfone (FDA-CFR-177.2440) Test: water, 50% alcohol, 3% acetic acid, N-heptane extractables Material: Polytetrafluoroethylene, perfluoroalkoxy (FDA-CFR-177.1550) Test: water, 50% alcohol, N-heptane, ethyl acetate extractables (FDA-CFR-177.1550)
USA Materials Laboratory needed for Intermittent testing of 3 foam sample hardness over 30,60,90,120, and 150 wash cycles. Machine wash warm, tumble dry low.Wash & Dry Equipment & Durometer to test foam hardness changes
USA Clinical CLIA certified lab needed to perform split specimen genetic testing on at least 5 patients. We are specifically interested in the following genes: CYP3A4 CYP3A5 CYP2B6 CYP1A2 OPRM1 COMT MTHFR SLCO1B1
Biomechanical Laboratory needed for CE Mark Testing of Biomechanical Titanium Material for Titanium Purpose
Canada / US Microbiology Laboratory needed for Repeat cleaning and steam sterilization cycle test for medical device component.
Physical Laboratory needed for medical elastic bandage testing for the force it generates at 50% extension and various elongations. The customer states it must be 1.35 foot pounds at 50% extension.
Medical Device Product Safety Laboratory needed for Stability Testing and Biodegradability Testing of Nature latex foley balloon catheter ,Scalp vein sets, feeding tube (PVC) ,and other surgical disposable product to ISO 10993, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
Microbiology Contract Laboratory needed for conducting a stability study for one of our products that require 3 chambers at 25C/50%RH. This study will start in November, 2015 at the earliest. These chambers will need to be dedicated exclusively for us.
Packaging Laboratory needed for ASTM Testing to ASTM D4169, Standard Practice for Performance Testing of Shipping Containers and Systems
Medical Device Physical Laboratory needed for mechanical function testing of reusable device after Cleaning and steam sterilization. 63 reusable laparoscopic handles tested according to the IFU for 100 repeat clean/sterilize cycles. Test the mechanical function after every 10 cycles.
Asia clinical laboratory for biopsy and blood testing: Measure telemers from various blood and biopsy samples
Microbiology Laboratory needed for anti-microbial efficacy testing of Anti Microbial Surface Coating with various Virus like H1N1 , Corona etc.
Medical Device Product Safety Toxicology Laboratory needed for Product Safety Studies including Cytotoxicity Testing & endotoxin testing
Medical Technology and Microbiology Laboratory needed for stability accelerated ageing testing & sterility test for the product has been manufactured in 05/2013 and sterilized by Ethylene Oxide. This product expire in 05/2016 so we want to perform the accelerated ageing test and sterility test to extend the shelf life for another 2 years (to 05/2018).
Medical Device Laboratory needed for solvent removal process validation testing of a drug/device combination product. Please provide a quotation to conduct a TGA scan on a single sample (to establish conditions under which all the ethanol is driven off) followed by testing of six samples (three batches in duplicate) to validate the solvent removal capability of the manufacturing process.The device is manufactured using a Class 3 residual solvent (ethanol) which is the only volatile species likely to be present. The ethanol may not be readily volatilized because it is a component in a viscous gel.
Medical Device laboratory needed for efficacy study of a new contact lens cleaning device: comparison study in cleanness (how much dirt, built up protein, particles, bacteria and micro-organisms are left after the lens has been cleaned) between a normal rinse and rub and this new device. Is this something your lab could potentially do?
Medical Device Product Safety Laboratory needed for FDA 510k biocompatibility testing to ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry [Including: Amendment 1 (2013)]
Need to do testing for FDA 510k submission for Zirconium Milling disks
Medical Technology laboratory needed for Laser resistance testing per ISO 11810 for disposable surgical drape
USA product safety laboratory needed for product safety assessment testing to sell a skin patch on Amazon.
US analytical chemistry laboratory needed for analysis of food grade, fresh water, silica/diatomaceous earth.
USA Medical Laboratory needed for GS/MS water testing: Detecting approximately 200 to 400 ppb ethylene oxide in water sample
Medical Device Laboratory needed for Residual ethylene oxide and ethylene chlorohydrin testing of medical devices in compliance with ISO 10993-7
Packating Laboratory needed for ISO 11607 and FDA CE ISO 13485 requirements for Medical device packaging testing for gamma sterilized device, aging, validation, report , SOP, IQ, PQ, VQ Etc. Needed as soon as possible
Diagnostics manufacturer needs bioanalytical laboratory needed for Residual Moisture Analysis of lyopholized serums.
Preclinical Medical Device Laboratory needed for Medical Devices Vibration testing, Medical Devices Impact, Medical Devices Electromagnetic Compatability Testing EMC Testing
Medical Device Laboratory needed for product development testing of sample collection product that is compatible with Vitros and Cobas instruments as well as manual ELISAs. We're looking for labs to finish product development with and direct lab tests to. We're planning to offer on-demand medical testing to e-doctor sites and apps.
Polymer test laboratory needed for BSE/TSE testing and chemical analysis of medical device injectors
India biomedical laboratory needed for ISO dental implant testing: Cyclic load testing on dental implants 15Hz for 5 million cycles and Dynamic fatigue testing ISO 14801 on dental implants
Arizona and Texas licensed clinical Laboratory needed with insurance contracts BC/BS United Cigna and Aetna.
India biophysical laboratory needed for dental implant testing: Dynamic fatigue testing ISO14801 on dental implants to ISO 14801, Cyclic load testing on dental implant at 15Hz -5 million cycles . 20 implant testing in a span of 2 years.
Medical Device Microbiology Laboratory needed for sterilization validation testing of Class 1 medical device used as implants.
Microbiology Laboratory needed for Microbiology Testing of Neurology Electrode Medical Devices
FDA registered, cGMP and ISO biomedical / toxicology laboratory needed for product safety testing of a transient use(<15 minutes), mucosal (non-breaching), device:
1. ISO 10993-5 Cytotoxicity testing
2. ISO 10993-10 Sensitization Testing
3. ISO 10993-10 Vaginal Irritation Testing
Biomedical and Product Safety Laboratory needed for breast implant testing toISO 10993. We would like to test: 1) 2) INTRAGASTRIC BALLOON 3) BREAST IMPLANT on the next effects: 1) CYTOTOXITY 2) IMITATION (INTRACUTANEOUS REACTIVITY) 3) SENSITILIZATION 4) SYSTEMIC TOXICITY (ACUTE) 5) IMPLANTATION 6) SUBCHRONIC TOXICITY 7) GENOTOXITY
USA Clinical Biomedical Laboratory needed for clinical Testing the safty and comfort of non-invasive medical procedure applying radio frequency for treatment of tonsillitis.
FDA GMP medical device company needed for contact lens testing in compliance to go for FDA approval
Medical Device Materials Laboratory needed for contact lens testing services provided for measurement of Ion Permiability, Oxygen Permiability, Power, Light Transmission, Diameter, Contact Angle, and Visual Inspection of contact lenses as well as pH, Osmolality of storage solution and package condition.
Healthcare System needs Microbiology Laboratory for suture testing to determine the source of a cluster of post operative infections
ISO or FDA GMP Boston product safety laboratory needed for wound dressing product safety and biocompatibility testing.
ISO and FDA GMP Medical Technology Microbiology Laboratory needed for ISO surgical instument sterilization validation.in need of a lab that can confirm inactivation of prions via NaOH or sodium hypochloride bath
Genetics laboratory needed that can process genetic and UDT testing in Southern CA ( LA County or Orange County) for Nationwide distribution company
Product Safety Laboratories needed for product safety testing to EN ISO Standards:EN ISO 10993-10 Biological evaluation of medical devices. Tests for irritation and delayed-type hypersensitivity, , EN ISO 10993-05 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity , 10993-03 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
University Researcher needs China Nuclear Chemistry Laboratory for Radiation Exposure Testing to UV, X-Rays
Europe biomedical laboratory needed for CE Mark testing protheses testing of tubular adapters for lower limb prostheses (amputees) ISO Standard 10328:2006 mechanical tests (torsional testing - static testing) and
Structural tests : static test under load Structural tests : static rupture tests Structural tests : cyclic tests Torsional tests
USA Healthcare Research Institute needs clinical laboratory for blood Serum testing: Adeno Associated Virus Antibody testing
Southern California Biomedical Laboratory needed for Biomechanical analysis Examine the potential of device for building strength and mass and for rehabilitation
Boston Area Bioanalytical laboratory needed for medical device research experiment with the ability of a water-jet device to cut and consume various Collagen types. Specifically it's ability to differentiate between type 1 and 3 collagen.
Medical Device Materials Laboratory needed for ASTM biodegration testing to support biodegradable claim for a patient belonging bag. We're hoping to get the test done per a standard; we've identified ASTM D5511 (Anaerobic Biodegradation of Plastics) or ASTM D6954 (Oxo-Biodegradable Plastics).
University Medical Researcher needs United States food laboratory for phthalate and phthalte metabolite testing for the phthalate levels in several different milk and milk derivative samples (organic and non organic products) in order to determine at what stage of processing phthalates become introduced to these foods. We're also observing whether organic vs. nonorganic sources pose differences in terms of when these chemicals are introduced and to what extent they are present. We want to correlate this data with a more clinical aspect of our studywhich looks at these phthalate/phthalate metabolite levels in patients. We are observing how BMI affects the presence of these chemicals in adult female patient blood samples and are hoping to observe effects of these chemicals on fertility.
We would like to test for the following and are
Asia polymer laboratory needed for ASTM Testing to test PEEK material according to ASTMF 2026. Please kindly let me know if you have this facility and if so, please send me a quotation.
INDIVIDUAL: Laboratory needed for breastmilk testing to determine if it is breastmilk or if it is infant formula. (Essentially, to determine conclusively whether or not the liquid is breastmilk. There is the possibility it is supplemented with cow's milk, or is entirely infant formula).
OR: comparison of "breastmilk" with the (reconstituted by the lab) powdered infant formula which the client believes is being provided, (client will provide a new, sealed container of the infant formula which client believes is being passed off as breast milk) in order to determine the likelihood that the "breastmilk" and the powdered formula are the same substance.
India Medical Device Laboratory needed for Radiopecity Testing of Microcatheter (Plastic Extuded component) using X-Ray System-Glenbrook Technologies MXRA, MXXR
Analytical Chemistry Laboratory needed for research testing on the vegetable oil used in a medical device used in hospitals to support "mold and hold" patients to allow relief from pressure ulcers. Tried Soy Oil in device and it works well, but developed an odor, and varied fom load to load.
United States textiles laboratories needed for verification testing of the compression rating & fiber content of compression socks.
Singapore or USA medical device laboratory needed for ASTM MRI / radiopaque testing of endotracheal and tracheostomy tubes to ASTM F2503-13, ASTM F2213 and ASTM F2503
Bioanalytical laboratory needed for TSE / BSE validation testing to validate that research products is 100% free of TSE Transmissible spongiform encephalopathies/BSE Bovine Spongiform Encephalopathy.
USA Microbiology Research Laboratory needed for tissue testing. Determine the presence of biofilm from infected tissue such as a tissue staining methods that identify biofilm?
Medical Device Laboratory needed for ANSI Testing Device of an aqueous ocular shunt to ANSI Z80.27, Ophthalmics - Implantable Glaucoma Devices. The test would involve characterising the pressure/ flow characteristic.
United States Toxicology Laboratory needed for toxicology testing on a variety of plastic materials for orthodontic usage.
UK Biomedical Laboratory needed for clinical trial testing: 80 x 3 day faecal samples to be analysed for coefficient of nitrogen absorption AND coefficient of fat absorption.
Medical University Researcher needs Microbiology Laboratory needed for anti-viral efficacy testing for In vitro antiviral activity of a poly herbal formulation against H1N1 and chikungunya virus.
USA materials laboratory needed for Drapability testing of a medical sterilization wraps (textile) from 2 conditions of differing autoclave time, described below. There will be 40 wrapped samples total (10 samples per condition and item number
Israel cosmetics analytical chemistry laboratory needed for water resistance testing of a cosmetic.
United States Laboratory needed for 12 lead electrocardiograph testing against IEC/AAMI standards ISO 60601-1, ISO 60601-1-2, AAMI EC11
United States medical device laboratory needed for formulation testing to add flavoring to denture adhesive remover in Powder form.
Medical Device Laboratory needed for ISO Testing of medical device: Pressure/force testing - need to measure how much force a fluid has as it is ejected from a device test to: ISO 5367 and EN 12342
Medical Device Laboratory needed for Medical Device Testing to ASTM 640-12, Standard Test Methods for Determining Radiopacity for Medical Use
Northern California biochemical laboratory needed for formulation testing to Finalize chemically based optical sensor formulation for use in a disposable medical device and develop manufacturing specifications
USA Biomedical Laboratory needed for ISO Testing of Japanese polyester fiber to ISO 10993-5 (cytotoxicity) and ISO 10993-10 (skin irritation)
United States FDA GMP bioanalytical laboratory needed for condom compatibility testing or water-based personal lubricant for condom compatibility. The data will be used to get approval through 510K approval pathway.
Biomedical Laboratory needed for insulin pen testing: test lab to carry out Dose accuracy test (As per ISO 11608-1:2014) of insulin pen device.
ISO Ontario, Michigan, or New York Biomedical Laboratory needed for Biomedical Testing of Plastic models of the Pelvis (axial torsion, strength until failure, etc.) using an Instron (preferably table top) materials testing machine
INDIVIDUAL TESTING: Clinical diagnostics laboratory needed for individual genetics testing of Y chromosome . Samples need to be mailed from Macedonia as there is no genetics laboratory there.
Medical Device Manufacturer needs independent test laboratory for verification testing of device that measures [CO] in expired air. We calibrate this device using primary standards from a well-known supplier. As a risk mitigation, we would like to have an independent laboratory verify the gas concentrations in these primary standards. The two mixtures of greatest interest are: 5 ppm ± 1% CO, balance N2 and 25 ppm ± 1% H2, balance N2.
USA Medical Device Laboratory needed for testing to EN388, Gloves Giving Protection from Mechanical Risks: Resistance to abrasion, Blade cut resistance, Tear resistance, Puncture resistance
Bioanalytical Laboratory needed for development testing for commercialization of isothermal assay (LAMP)
East Coast USA FDA GMP Bioanalytical Laboratory needed for testing analytical specificity of a rapid antigen testing. Testing potentially cross reacting organisms (parasites, viruses, bacteria) in whole blood with our rapid test. testing of 23 BLS2 organisms - some may have restrictions associated with them. Testing of BLS3 would be also requested, but not required if BLS3 facility not available.
URGENT: India Product Safety Toxicology Laboratory needed for Toxicokinetic Study: Biological Evaluation testing of product as per ISO 10993-16:2010 (Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables).
Clinical bioanalytical Laboratory needed for medical device diagnostic kit's effectiveness for for testing testosterone antibodies in pregnant women's urine
New Jersey bioanalytical laboratory needed for enzyme analysis of lubricating gel for Enzyme detection (analysis).
United Kingdom medical device laboratory needed for Fatigue testing on breast medical implant device (breast)to ISO 14607 Annex E, Non-active surgical implants. Mammary implants.
Medical Device Laboratory needed for ASTM Testing of air ventilators to ASTM D5466-01 Standard Test Method for Determination of Volatile Organic Chemicals in Atmospheres (Canister Sampling Methodology)
USA Medical Device Laboratory needed for dental sterilization testing to ISO 14457 : 2012 Dentistry ? Handpieces and motors (including Section 5.10 Repocess(250 sterilization cycles) test) Item: Dental Handpiece and coupling. This Requestor requires a Quote. Please respond with a quote.
Canada FDA GMP medical device laboratory needed for personal lubricant testing in support of a FDA 510(k) for the intent to sell in the United States.
USA Bioanalytical Preclinical Laboratory needed for bioanalysis: cytokine testing from micro-dialysis fluid for company completing research on burn scars and testing for certain cytokines levels in micro-dialysis fluid from the scar areas. Approx 72-108 samples. Cytokines to be analyzed include TGF-beta, TGF-B1, Decorin, TNF-alpha, IL-4,6,10, LSP-1, CTGF and VEGF