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
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