Difco Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 121
What Difco Laboratories, Inc. makes
Difco Laboratories, Inc. manufactures microbiological reagents and diagnostic tools, including differentiation disks for antibiotic susceptibility testing (e.g., vancomycin, clindamycin), spot test reagents (e.g., Voges-Proskauer), and specialized transport systems for pathogens (e.g., anaerobic transport pouches, viral transport packs). The portfolio also covers direct detection systems for infectious agents, such as the Chlamydia Direct Detection System, and coagulase testing strips for bacterial identification.
The company’s products are regulated under FDA’s Class I and Class II device classifications, with many cleared via the 510(k) pathway. These items are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 121 devicesShowing 1-50 of 121
Frequently asked questions
How many devices does Difco Laboratories, Inc. have in the registry?
The registry currently lists 121 devices for Difco Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Difco Laboratories, Inc.'s devices?
Among its 50 most recently registered devices, Difco Laboratories, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Difco Laboratories, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Difco Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Difco Laboratories, Inc. in the registry?
The most recently registered devices listed for Difco Laboratories, Inc. include DIFFERENTIATION DISKS VANCOMYCIN 5 MCG, DISPENS-O-DISC(TM) NITROCEFIN, DIFFERENTIATION DISKS BILE ESCULIN and SPOTTEST VOGES-PROSKAUER REAGENT A.