Contract Laboratory is the first and leading platform for expediting laboratory testing and scientific research. Find, compare and communicate with Laboratories and Lab Suppliers. Quickly and easily.

Need Laboratories or Lab Suppliers?

Need Laboratories or Lab Suppliers?

Create FREE Account

Need Laboratory Help?

Contract Us
>

Laboratory Test Request Details

Medical Devices and In-Vitro Diagnostics Test Request


Request: 16-01159

Status: Closed


Description:

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
Pyrogenicity
For products that remain in the body for greater than 30 days, the following additional tests are recommended:
Subchronic toxicity
Chronic toxicity
Long term carcinogenicity studies should be performed with any device in which a positive genotoxitiy test result was obtained.


Interested in this Medical Devices and In-Vitro Diagnostics Request?

Members of our Laboratory Outsourcing Network can use our online platform to communicate with the Lab Requestor, submit responses with quotes and have access to more information such as budget, location required, etc.

Create FREE Account


Healthcare and Medical ,Medical Devices and In-Vitro Diagnostics,Pharmaceuticals and Biopharmaceuticals,Polymers

Need Medical Devices and In-Vitro Diagnostics Testing or Scientific Research?

Save time and money searching. Simply, submit a Medical Devices and In-Vitro Diagnostics request to find the laboratories or lab suppliers that best meet your needs.

Submit Laboratory Request

Test Request: 19-01062

Manufacturing Company needs laboratory for NIST traceable dimensional measurements of custom part that there is only one... view


Test Request: 19-01061

Well Company needs geology laboratory for composition testing of 10 rock and mineral samples view


Test Request: 19-01060

Contract Laboratory needed for e-liquids testing including HPHC Testing for liquid, aerosol, stability tests, and leacha... view