Laboratory Test Request

Hemostatic IV Catheter Dressing GLP Antimicrobial Tests for FDA 510k

Project Description

PRODUCT DEVELOPMENT
MULTIPLE TESTS
FDA GMP Pharmaceutical Microbiology Laboratory needed for GLP antimicrobial tests of antimicrobial hemostatic IV catheter dressing :
1. AATCC 100 test
2. Zone of inhibition test (Kirby-Bauer method by the American Society for Microbiology)
The antimicrobial hemostatic IV dressing should maintain the antimicrobial performance for up to 7 days, so the AATCC 100 and Zone of inhibition tests should be performed for 7 days.
The test organisms are the followings:
1. AATCC 100 test (a total of 9 strains): S. aureus (MRSA), S. epidermidis (MRSE), E. faecium (VRE), P. aeruginosa, A. baumannii, K. pneumoniae, E. coli, C. albicans, and A. niger
2. Zone of inhibition test (a total of 8 strains): S. aureus (MRSA), S. epidermidis (MRSE), E. faecium (VRE), P. aeruginosa, A. baumannii, K. pneumoniae, E. coli, and C. albicans
I would like to perform the same antimicrobial tests as
Please confirm the availability of these tests and send us the pricing for these tests (triplicates).
I would be grateful for your prompt reply.
Feel free to email me for further clarification.
Thank you for your time.

Project Information

Number:22-01854

Industry:Medical Devices

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