# Biomerieux Vitek, Inc.

- Location (FDA's records): Hazelwood, MO
- FDA decisions: 50 (1978–1998): 49 510(k) clearances and 1 original PMA approval
- Product codes: GJT (5), LGD (3), LIQ (2), LQL (2), CHP (2), LJC (1), GHH (1), JXA (1), JWX (1), JLW (1), DAP (1), KFF (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 16 (0 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- American Bioproducts Co.: 1 (https://510kreport.com/company/american-bioproducts)

## Firms that cite its devices most
- bioMerieux, Inc.: 5 (https://510kreport.com/company/biomerieux)
- Bio-Rad Laboratories, Inc.: 3 (https://510kreport.com/company/bio-rad-laboratories)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- Diagnostic Products Corp.: 1 (https://510kreport.com/company/diagnostic-products)
- Bayer Diagnostics Corp.: 1 (https://510kreport.com/company/bayer-diagnostics)
- Combact Diagnostic Systems, Ltd.: 1 (https://510kreport.com/company/combact-diagnostic-systems)
- Radiometer Medical Aps: 1 (https://510kreport.com/company/radiometer-medical)

## Its most-cited devices
- K923166: Vidas Toxoplasma Gondii Igm Asssay (1993), cited by 6
- K973819: Vidas D-Dimer (DD) Assay (1998), cited by 2
- K933549: Vidas CMV Igm Assay (1994), cited by 2
- K924218: Bac-T-Screen (1993), cited by 1
- K922737: Vidas Toxo IG6 Assay (TX6) (1993), cited by 1
- K921816: Vitek Immun Assay Sys (Vidas) Thyroi Stim Hor Assay (1992), cited by 1

## Recent decisions
- K973819: Vidas D-Dimer (DD) Assay (Mar 10, 1998)
- K972895: Vidas Rotavirus (RTV) Assay (Oct 3, 1997)
- K965092: Vidas Rotavirus Assay (May 5, 1997)
- K964887: Vidas C. Difficile Toxin a II Assay (Apr 8, 1997)
- K955627: Vidas Chlamydia Blocking Assay (Oct 7, 1996)
- K962549: Vidas Creatine Kinase MB Assay 30-421 (Aug 30, 1996)
- K962609: Gram Negative Identification Plus Card (Aug 30, 1996)
- K952095: Vitek Gram Positive Identification Card (Gpi) (Mar 12, 1996)

Source page: https://510kreport.com/company/biomerieux-vitek