# Biomerieux, Inc. (manufacturer, Hazelwood, MO): 11 new FDA device listings, incl. susceptibility test cards, antimicrobial

**Score:** 95/100

| Field | Value |
|---|---|
| Establishment | Biomerieux, Inc. |
| Owner / operator | Biomerieux SA |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Hazelwood, MO, US |
| New listings | 11 |
| Devices | Susceptibility Test Cards, Antimicrobial; System, Test, Automated, Antimicrobial Susceptibility, Short Incubation; Panels, Test, Susceptibility, Antimicrobial; Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples |
| Product codes | LTW, LON, LTT, SAN |
| Device classes | Class II |
| Medical specialties | Microbiology |
| Brand names | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance; VITEK 2 AST-Streptococcus Cefepime; VITEK 2 AST-Streptococcus Cefuroxime; VITEK REVEAL Sealer; VITEK REVEAL Sensor Panel; VITEK REVEAL BC GN02-AST; VITEK REVEAL |
| First new listing | 2026-05-12 |
| Latest new listing | 2026-09-29 |
| FDA registration number | 1950204 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.