Laboratory Test Request Description

FDA 510(k, GLP, ISO, ASTM Bioanalytical and Microbiology Laboratory needed for the following:
Medical Device Sterility Testing
Medical Devices Microbiology Testing
Medical Device Microbial Identifications Testing
Medical Device USP Microbial Limits Testing
Medical Device USP, AAMI, EP Bacteriostasis/Fungistasis Testing
Medical Device Product Inoculations Testing
Medical Device Bioburden Testing
Total Fungi Testing
Total Aerobes Testing
Total Coliforms Testing
Ethylene Oxide Biological Indicators Performance Testing
Steam Biological Indicators Performance Testing
Medical Device Sterilization Validation
Medical Device Sterilization Dose Validation
Medical Device AATCC and ASTM Antimicrobial Testing
Medical Devices Ethylene Oxide Residuals Testing
Medical Devices In-Vivo USP, JP, EP Pyrogen Testing
Medical Devices Bacterial Endotoxin Testing - Limulus Amebocyte Lysate LAL Testing
Medical Devices Bacterial Endotoxin Testing - Gel Clot Testing
Medical Device Radiological Testing
Medical Device Environmental Monitoring Testing
Reusable Device Studies Testing
Medical Device Barrier Testing
Medical Device Product Safety Testing
Medical Device Container/Closure Testing
Medical Device Leachables Testing
Medical Device Biomaterial Extracts Protein Assays
Medical Device ASTM Extractables Testing
Need estimates within the week for budget deadline


Number: 09-1744


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