Biomerieux S.A.
FranceFDA applicant, unverified
- Devices
- 16
What Biomerieux S.A. makes
Biomerieux S.A. manufactures antimicrobial susceptibility testing strips (ETEST) for antibiotics like Delafloxacin, Piperacillin/Tazobactam, and Telavancin, as well as combination therapies such as Imipenem/Relebactam and Meropenem/Vaborbactam. Their portfolio also includes rapid diagnostic assays for *Clostridioides difficile* (VIDAS C DIFFICILE GDH) and Lyme disease markers (VIDAS LYME IGG/IGM), alongside selective agar media like CHROMID CARBA for detecting carbapenemase-producing organisms.
The company’s products are classified under FDA’s Class I and Class II regulatory categories, with several authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 16 devicesFrequently asked questions
How many devices does Biomerieux S.A. have in the registry?
The registry currently lists 16 devices for Biomerieux S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biomerieux S.A.'s devices?
Among its 16 most recently registered devices, Biomerieux S.A. has devices listed in EUDAMED (7 devices), FDA 510(k) (16 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Biomerieux S.A.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for Biomerieux S.A.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biomerieux S.A. in the registry?
The most recently registered devices listed for Biomerieux S.A. include ETEST Delafloxacin (DFX) (0.002-32 µg/mL), ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL), ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) and Etest Ceftaroline (0.002 - 32ug/ml).