Biomerieux Vitek, Inc.
United StatesFDA applicant, unverified
- Devices
- 50
What Biomerieux Vitek, Inc. makes
Biomerieux Vitek, Inc. manufactures automated immunoassay systems, such as the VIDAS platform, for detecting and quantifying hormones, enzymes, and infectious agents in clinical samples. Their portfolio includes specific assays like thyroid-stimulating hormone, creatine kinase MB, rotavirus, and total immunoglobulin E (IgE), as well as reagents for hematology testing under the HEMOLAB brand. Rapid diagnostic kits, such as the SLIDEX Staph-Kit, are also part of their offerings for point-of-care or laboratory use.
The company’s devices are regulated under FDA pathways, including 510(k) clearances for Class II products and PMA authorizations for higher-risk Class I devices. These systems are listed in the FDA’s regulatory databases for in vitro diagnostics, ensuring compliance with U.S. medical device standards. The manufacturer operates from the United States.
Catalogue
Search and filter all 50 devicesFrequently asked questions
How many devices does Biomerieux Vitek, Inc. have in the registry?
The registry currently lists 50 devices for Biomerieux Vitek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biomerieux Vitek, Inc.'s devices?
Among its 50 most recently registered devices, Biomerieux Vitek, Inc. has devices listed in FDA 510(k) (49 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Biomerieux Vitek, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Biomerieux Vitek, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biomerieux Vitek, Inc. in the registry?
The most recently registered devices listed for Biomerieux Vitek, Inc. include VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY, HEMOLAB, VIDAS CREATINE KINASE MB ASSAY 30-421 and VIDAS ROTAVIRUS (RTV) ASSAY.