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BIOMERIEUX , INC.

US

Last updated September 17, 2026

What BIOMERIEUX , INC. makes

The company manufactures in vitro diagnostic (IVD) devices for microbial identification and antimicrobial susceptibility testing, including antimicrobial susceptibility culture media, microorganism identification analysers, and blood culture analysers. Notable products include antimicrobial gradient test strips (e.g., ETEST®), automated microbial identification systems (e.g., VITEK®), fluorescent immunoassay analysers (e.g., VIDAS®), and mass spectrometry-based microbial identification systems (e.g., VITEK® MS). Additional offerings include selective/differential agar media, nutrient broth culture media, and disposable consumables for automated extraction systems.

These devices are classified under FDA’s Class I, Class II, and Class III regulatory categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates under U.S. regulatory oversight, with devices authorised for commercial distribution in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Biomerieux, Inc. manufacture?

Biomerieux, Inc. specializes in in vitro diagnostic (IVD) devices focused on microbial identification and antimicrobial susceptibility testing. Their products include antimicrobial gradient test strips (like ETEST®), automated systems for microbial identification (such as VITEK® and VITEK® MS), fluorescent immunoassay analysers (e.g., VIDAS®), culture media (e.g., selective/differential agar and nutrient broth), and blood culture analysers (e.g., BACT/ALERT®). These devices support laboratory workflows in infectious disease diagnostics.

Where is Biomerieux, Inc. based, and how does that affect its regulatory oversight?

Biomerieux, Inc. is based in the United States, which means its devices fall under FDA regulatory jurisdiction. Since the company manufactures IVDs, its products are authorised through the FDA’s premarket authorisation processes, including 510(k) clearances or PMA approvals for Class II and Class III devices, respectively. The FDA’s UDI database lists its authorised devices, ensuring traceability and compliance tracking.

Which regulatory registries or databases list Biomerieux, Inc.’s devices?

Biomerieux, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry assigns a standardized identifier to each authorised device, enabling transparency in tracking and compliance. The UDI system helps healthcare providers, regulators, and distributors verify device details, including classification and authorisation status.

How are Biomerieux, Inc.’s devices classified under FDA regulations?

Biomerieux, Inc.’s devices are classified into three FDA categories: Class I (generally low-risk, with minimal regulatory controls), Class II (moderate-risk, requiring special controls to ensure safety and effectiveness), and Class III (high-risk, requiring premarket approval due to insufficient data to assure safety and performance). Classification depends on factors like the device’s intended use, potential risks, and the level of regulatory oversight required to mitigate those risks.

What is the primary purpose of Biomerieux, Inc.’s antimicrobial susceptibility testing devices?

The primary purpose of Biomerieux, Inc.’s antimicrobial susceptibility testing devices—such as ETEST® gradient strips and VITEK® systems—is to determine the effectiveness of antibiotics against specific microorganisms. These devices help laboratories identify the minimum inhibitory concentration (MIC) of antimicrobials, enabling clinicians to prescribe targeted treatments and reduce the risk of antibiotic resistance. This supports precision medicine in infectious disease management.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
3015 Carrington Mill Blvd, Morrisville, NC, 27560
Website
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LinkedIn
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Facebook
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Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3031977134
DUNS Number
086785110

Catalogue (704)

Page 3 of 15
DeviceModel / ReferenceRegistriesClassStatus
VIDAS® H. pylori IgG 30192-01
FDA UDI
Class IActive
Bact/Alert® 3d Left Combination Module 200291
FDA UDI
Class IActive
Vitek®2 27227R
FDA UDI
Class IIActive
BacT/ALERT® Blood Collection Adapter Cap BacT/ALERT® Blood Collection Adapter Cap
FDA UDI
Class IIUnknown
VIDAS® D-Dimer Exclusion II ™ 30455-01
FDA UDI
Class IIActive
ETEST® Benzylpenicillin (PG) ETEST® Benzylpenicillin (PG)
FDA UDI
Class IIActive
Etest® AMOXICILLIN Etest® AMOXICILLIN
FDA UDI
Class IIUnknown
VIDAS® Mumps IgG 30218
FDA UDI
Class IActive
Etest® TIC/CLAV-CON2 Etest® TIC/CLAV-CON2
FDA UDI
Class IIUnknown
ETEST® Ceftolozane/Tazobactam (C/T) ETEST® Ceftolozane/Tazobactam (C/T)
FDA UDI
Class IIActive
Vitek® 2 Ast-Gn76 VITEK® 2 AST-GN76
FDA UDI
Class IIActive
CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood (CPSE/CNA) CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood (CPSE/CNA)
FDA UDI
Class IActive
DensiCHEK™ plus 21250
FDA UDI
Class IIActive
Vitek® 2 Ast-Gn66 VITEK® 2 AST-GN66
FDA UDI
Class IIActive
Vitek® 2 Ast-Gn73 VITEK® 2 AST-GN73
FDA UDI
Class IIActive
ETEST® Cephalothin (CE) ETEST® Cephalothin (CE)
FDA UDI
Class IIActive
Worksafe™ Blood Culture Collection Kits: FAN®PLUS Worksafe™ Blood Culture Collection Kits: FAN®PLUS
FDA UDI
Class IActive
Vitek® 2 Kb Update V2s 9.04
FDA UDI
Class IIActive
ETEST® Benzylpenicillin (PG) ETEST® Benzylpenicillin (PG)
FDA UDI
Class IIActive
Xyl XYL
EUDAMEDFDA UDI
Class IActive
mini VIDAS® 99737
FDA UDI
Class IActive
Bact/Alert® Mp BACT/ALERT MP
FDA UDI
Class IActive
ETEST® Erythromycin (EM) ETEST® Erythromycin (EM)
FDA UDI
Class IIUnknown
Etest® PIP/TAZO/CON-4 Etest® PIP/TAZO/CON-4
FDA UDI
Class IIActive
Bact/Alert® 3d Control Module 210147
FDA UDI
Class IActive
PREVI® Color Gram RA3 ACETONE FUCHSIN solution 29584
EUDAMEDFDA UDI
Class IActive
API® 50 CHB/E Medium API® 50 CHB/E Medium
EUDAMEDFDA UDI
Class IActive
Vitek® 2 Ast-N812 VITEK® 2 AST-N812
EUDAMEDFDA UDI
Class IIActive
Vitek® 2 Ast-Xn08 VITEK® 2 AST-XN08
FDA UDI
Class IIActive
Zn Zn
EUDAMEDFDA UDI
Class IActive
Vitek® 2 Ast-Gn90 VITEK® 2 AST-GN90
FDA UDI
Class IIUnknown
Ehr 70520
EUDAMEDFDA UDI
Class IActive
Vidas® Hcg 30405-01
FDA UDI
Class IIActive
VITEK® DENSICHEK® Connectivity Base 422221
FDA UDI
Class IIActive
Vidas 3 1.3
FDA UDI
Class IActive
ETEST® Tobramycin (TM) ETEST® Tobramycin (TM)
EUDAMEDFDA UDI
Class IIActive
ARGENE® CINAkit HCMV ppUL83 US 19-0028US
FDA UDI
Class IIUnknown
Api® Listeria 10300
EUDAMEDFDA UDI
Class IActive
VIDAS® Serum Free VIDAS® Serum Free
FDA UDI
Class IIActive
ETEST® Cefepime (PM) ETEST® Cefepime (PM)
FDA UDI
Class IIUnknown
Vitek® 2 Ast-N814 VITEK® 2 AST-N814
EUDAMEDFDA UDI
Class IIActive
Vitek® 2 Ast-Xn15 VITEK® 2 AST-XN15
FDA UDI
Class IIActive
Vitek® 2 60 Blue Mod Colorm 27225
FDA UDI
Class IIActive
Previ® Color Cytocentrifuge 29506
FDA UDI
Class IActive
Vitek® 2 Ast-Gn48 VITEK® 2 AST-GN48
FDA UDI
Class IIActive
Api® 20 E API 20 E™
FDA UDI
Class IActive
Vitek® 2 Ast-Gn75 VITEK® 2 AST-GN75
FDA UDI
Class IIActive
Previ® Color Dual Sample Chambers Fast (white) PREVI® COLOR DUAL SAMPLE CHAMBERS FAST (WHITE)
EUDAMEDFDA UDI
Class IActive
ETEST® Meropenem/Vaborbactam (MEV) ETEST® Meropenem/Vaborbactam (MEV)
FDA UDI
Class IIActive
Vitek® 2 Ast-Gn49 VITEK® 2 AST-GN49
FDA UDI
Class IIUnknown

Related Companies

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Biomerieux, Inc. HAZELWOOD, MO · US FEI 1950204