Biomerieux, Inc. (manufacturer, Hazelwood, MO): 12 new FDA device listings, incl. susceptibility test cards, antimicrobial
Biomerieux, Inc. (Hazelwood, Missouri): 12 new FDA device listings, incl. susceptibility test cards, antimicrobial. Its amount of 12 is top-decile (94th percentile of 2,709 records). Dated 14 days ago, it is in the active follow-up window. Score 95/100. As of 2026-11-04, 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: 12 · 94th percentile of 2,709 DeviceEstablishmentPulse records · 6.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 13 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 | 12 |
| Devices | Susceptibility Test Cards, Antimicrobial; Panels, Test, Susceptibility, Antimicrobial; System, Test, Automated, Antimicrobial Susceptibility, Short Incubation; Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples |
| Product codes | LTW, LTT, LON, SAN |
| Device classes | Class II |
| Medical specialties | Microbiology |
| Brand names | VITEK 2 AST-Streptococcus Cefepime; VITEK REVEAL BC GN02-AST; VITEK REVEAL Sensor Panel; VITEK REVEAL Sealer; VITEK REVEAL; VITEK 2 AST-Streptococcus Meropenem; VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance; VITEK 2 AST-Streptococcus Cefuroxime |
| First new listing | 2026-05-12 |
| Latest new listing | 2026-10-22 |
| FDA registration number | 1950204 |
| Registration expires | 2027-12-31 |
| amount percentile | 94th of 2,709 (median 2, 6.0x median) |
| Peer records CSV (14 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: 2026-10-22
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (MO first): Midwest Sterilization Corp. (contract sterilizer, Jackson, M · Surgical Instrument Manufacturers, LLC (contract manufacture · Biomerieux, Inc. (manufacturer, Hazelwood, MO) · Steris Corporation (manufacturer, Saint Louis, MO) · Steris Corporation (repackager or relabeler, Breckenridge Hi · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Biomerieux, Inc. and 14 Missouri peers
- Missouri DeviceEstablishmentPulse records like this one: 14
- Biomerieux, Inc.'s amount: 94th percentile of 2,709 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Missouri peer: $2,800 (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 12 FDA device listings between 2026-05-12 and 2026-10-22.
How does Biomerieux, Inc. compare to other Missouri DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 12 is 6.0x the median of 2 across 2,709 records. It is fresh: dated 14 days ago, inside the window where early outreach matters most. 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 | 12 | 94th | 2026-10-22 |
| Intuitive Surgical, Inc. | Sunnyvale, CA | 13 | 95th | 2026-10-22 |
| Intuitive Surgical, Inc. | Santa Clara, CA | 13 | 95th | 2026-10-22 |
| Coopersurgical, Inc. | Trumbull, CT | 14 | 95th | 2026-10-20 |
Related records
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- Tornier, Inc.
- Treace Medical Concepts, Inc.
- Coopersurgical, Inc.
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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.