Biomerieux, Inc. (manufacturer, Hazelwood, MO): 11 new FDA device listings, incl. susceptibility test cards, antimicrobial
Biomerieux, Inc. (Hazelwood, Missouri): 11 new FDA device listings, incl. susceptibility test cards, antimicrobial. Its amount of 11 is top-decile (94th percentile of 2,570 records). Dated 37 days ago, it serves as a historical benchmark. Score 95/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 11 · 94th percentile of 2,570 DeviceEstablishmentPulse records · 11.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 10 related MO DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 94th of 2,570 (median 1, 11.0x median) |
| Peer records CSV (11 MO records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-09-29
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Biomerieux, Inc. and 11 Missouri peers
- Missouri DeviceEstablishmentPulse records like this one: 11
- Biomerieux, Inc.'s amount: 94th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Missouri peer: $2,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
95 / 100 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.
What is the DeviceEstablishmentPulse record for Biomerieux, Inc. in Hazelwood, Missouri?
Biomerieux, Inc. (Hazelwood, MO), a manufacturer, added 11 FDA device listings between 2026-05-12 and 2026-09-29.
How does Biomerieux, Inc. compare to other Missouri DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 11 is 11.0x the median of 1 across 2,570 records. It is 37 days old, still within a typical 45-day follow-up window. Its Score of 95/100 puts it among the stronger signals in this feed.
Biomerieux, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Biomerieux, Inc. | Hazelwood, MO | 11 | 94th | 2026-09-29 |
| Boston Scientific Corporation | Coventry, RI | 10 | 93rd | 2026-10-16 |
| Paragon 28 | Englewood, CO | 9 | 92nd | 2026-10-08 |
| Surgentec LLC | Boca Raton, FL | 15 | 96th | 2026-10-16 |
Related records
DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Missouri
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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.