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Sign in to claim this brandBIOMERIEUX , 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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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3031977134
- DUNS Number
- 086785110
Catalogue (704)
Page 4 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| VIDAS® CMV IgG | 30204-01 | FDA UDI | Class II | Active |
| Vidas® Ck-Mb | 30421-01 | FDA UDI | Class II | Unknown |
| ETEST® Ceftazidime (TZ) | ETEST® Ceftazidime (TZ) | FDA UDI | Class II | Active |
| Vitek®2 | 9.02.0 | FDA UDI | Class II | Active |
| ETEST® Erythromycin (EM) | ETEST® Erythromycin (EM) | FDA UDI | Class II | Active |
| ETEST® Ceftaroline (CPT) | ETEST® Ceftaroline (CPT) | FDA UDI | Class II | Active |
| ETEST® Tigecycline (TGC) | ETEST® Tigecycline (TGC) | FDA UDI | Class II | Active |
| Vidas® 3 Software V1.4 | 1.4 | FDA UDI | Class I | Active |
| Vitek® 2 Yst | VITEK® 2 YST | FDA UDI | Class I | Active |
| Vitek®2 | 9.01.1 | FDA UDI | Class II | Active |
| Vitek® 2 Ast-Gn77 | VITEK® 2 AST-GN77 | FDA UDI | Class II | Active |
| Api® Id-Ase | API® ID-ASE | EUDAMEDFDA UDI | Class I | Active |
| VIDAS® Lyme IgG II | 417401 | FDA UDI | Class II | Active |
| Previ® Color 12 Slides Carousel | 29557 | FDA UDI | Class I | Active |
| Vitek® 2 Ast-Xn19 | VITEK® 2 AST-XN19 | FDA UDI | Class II | Active |
| Vitek® 2 Ast-N811 | VITEK® 2 AST-N811 | FDA UDI | Class II | Active |
| Vitek® 2 Ast-Gp75 | VITEK® 2 AST-GP75 | FDA UDI | Class II | Active |
| CHROMID® VRE Agar | chromID™ VRE Agar | FDA UDI | Class II | Active |
| ETEST® Ampicillin (AM) | ETEST® Ampicillin (AM) | FDA UDI | Class II | Unknown |
| ETEST® Trimethoprim/Sulfamethoxazole (1/19) (TS) | ETEST® Trimethoprim/Sulfamethoxazole (1/19) (TS) | FDA UDI | Class II | Active |
| Vitek®2 | 9.01.0 | FDA UDI | Class II | Unknown |
| Vitek® 2 Ast-Gn87 | VITEK® 2 AST-GN87 | FDA UDI | Class II | Unknown |
| chromID® Strepto B agar | chromID® Strepto B agar | FDA UDI | Class I | Active |
| ETEST® Clindamycin (CM) | ETEST® Clindamycin (CM) | FDA UDI | Class II | Active |
| Vidas® T3 | 30403-01 | FDA UDI | Class II | Unknown |
| ETEST® ESBL Cefotaxime/cefotaxime + clavulanic acid (CT/CTL) | ETEST® ESBL Cefotaxime/cefotaxime + clavulanic acid (CT/CTL) | FDA UDI | Class II | Active |
| ETEST® Aztreonam (AT) | ETEST® Aztreonam (AT) | FDA UDI | Class II | Active |
| NTM Elite agar | NTM Elite agar | FDA UDI | Class I | Active |
| Bact/Alert® Sn | BACT/ALERT® SN | FDA UDI | Class I | Active |
| Vitek® 2 Ast-Xn30 | VITEK® 2 AST-XN30 | EUDAMEDFDA UDI | Class II | Active |
| PREVI™ Isola Applicator Cartrige | PREVI™ Isola Applicator Cartrige | FDA UDI | Class I | Unknown |
| ETEST® ESBL Ceftazidime/ceftazidime + clavulanic acid (TZ/TZL) | ETEST® ESBL Ceftazidime/ceftazidime + clavulanic acid (TZ/TZL) | FDA UDI | Class II | Unknown |
| James | 70542 | EUDAMEDFDA UDI | Class I | Active |
| ETEST® Itraconazole (IT) | ETEST® Itraconazole (IT) | EUDAMEDFDA UDI | Class II | Active |
| Vitek® 2 Ast-Gn68 | VITEK® 2 AST-GN68 | FDA UDI | Class II | Active |
| Etest® FLUCONAZOLE | Etest® FLUCONAZOLE | FDA UDI | Class II | Unknown |
| Vitek® 2 Ast-N815 | VITEK® 2 AST-N815 | FDA UDI | Class II | Active |
| Vitek® 2 Compact | 27560 | FDA UDI | Class II | Active |
| Vidas® Cea (s) | 30453-01 | FDA UDI | Class II | Unknown |
| Bact/Alert® 3d Right Incubation Module | 210161 | FDA UDI | Class I | Active |
| Bact/Alert® Pf | BACT/ALERT® PF | FDA UDI | Class I | Active |
| Previ® Color Poly-L-Lysine Slides Single | PREVI® COLOR POLY-L-LYSINE SLIDES SINGLE | FDA UDI | Class I | Active |
| Etest® CEFOTAXIME | Etest® CEFOTAXIME | FDA UDI | Class II | Unknown |
| ETEST® Azithromycin (AZ) | ETEST® Azithromycin (AZ) | FDA UDI | Class II | Active |
| Vitek® 2 Ast-Gn95 | VITEK® 2 AST-GN95 | FDA UDI | Class II | Active |
| Vitek® 2 Ast-N807 | VITEK® 2 AST-N807 | EUDAMEDFDA UDI | Class II | Active |
| Vitek® Reveal™ Bc Gn02-Ast | VITEK® REVEAL™ BC GN02-AST | FDA UDI | Class II | Active |
| ETEST® Cefoxitin (FX) | ETEST® Cefoxitin (FX) | FDA UDI | Class II | Active |
| chromID™ Candida Agar | chromID™ Candida Agar | FDA UDI | Class I | Active |
| Apiweb™ | 1.4 | FDA UDI | Class I | Active |
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