ATCC is here to support your medical device premarket submissions to the Food and Drug Administration (FDA) with a diverse array of fully authenticated and well-described microbial strains and nucleic acids recommended by guidance for industry. Each culture’s defined characteristics, along with documented isolation history, allows for the easy selection of strains recommended for testing medical devices for:
- Sterility
- Presence/absence of multidrug-resistant organisms
- Assay-based inclusivity/exclusivity
- PCR-based limits of detection
For more information about ATCC products that support the evaluation of novel medical devices, please visit us online at www.atcc.org/QC.
