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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
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Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3031977134
DUNS Number
086785110

Catalogue (704)

Page 12 of 15
DeviceModel / ReferenceRegistriesClassStatus
Vitek 2 Yeast Voriconazole K092454
FDA 510(k)
Class IIActive
Cystine Tryptic Agar W/Lactose K844543
FDA 510(k)
Class IActive
Fluid Thioglycollate Medium W/Indicator K844537
FDA 510(k)
Class IActive
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO K161816
FDA 510(k)
Class IActive
Urea Agar K844548
FDA 510(k)
Class IActive
VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL) K162737
FDA 510(k)
Class IIActive
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) K211630
FDA 510(k)
Class IIActive
Brilliant Green Agar K871094
FDA 510(k)
Class IActive
Vitek(r) 2 Streptococcus Tetracycline K111893
FDA 510(k)
Class IIActive
Vitek 2 Gram Positive Meropenem K050816
FDA 510(k)
Class IIActive
Vitek Gram Negative Gatifloxacin K032711
FDA 510(k)
Class IIActive
Mda D-Dimer K021877
FDA 510(k)
Class IIActive
Gram Postitve Clindamycin K122547
FDA 510(k)
Class IIActive
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) K183524
FDA 510(k)
Class IIActive
Vitek Gram Negative Susceptibility (gns) Card For Moxifloxacin K043237
FDA 510(k)
Class IIActive
BACT/ALERT MP Reagent System K190405
FDA 510(k)
Class IActive
Vitek 2 Ast-Gn Piperacillin/Tazobactam K113200
FDA 510(k)
Class IIActive
Dtm Agar K844514
FDA 510(k)
Class IActive
Gn Broth K844524
FDA 510(k)
Class IActive
Vitek 2 Streptococcus Levofloxacin K112228
FDA 510(k)
Class IIActive
Chocolate Agar, Enriched K830074
FDA 510(k)
Class IActive
Vitek 2 Gram Negative Levofloxacin K072038
FDA 510(k)
Class IIActive
Tryptic Soy Broth W/6.5%sodium Chloride K844547
FDA 510(k)
Class IActive
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) K170670
FDA 510(k)
Class IIActive
Mueller Hinton W/50% Sheep Blood K830059
FDA 510(k)
Class IActive
Vitek 2 Ast-Ys Fluconazole K061945
FDA 510(k)
Class IIActive
Vitek 2 Gram Negative Tigecycline K052311
FDA 510(k)
Class IIActive
Tryptic Soy Agar K871098
FDA 510(k)
Class IActive
Thioglycollate W/O Indicator K844536
FDA 510(k)
Class IActive
Bismuth Sulfite Agar K830079
FDA 510(k)
Class IActive
Nutrient Broth K844528
FDA 510(k)
Class IActive
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) K212849
FDA 510(k)
Class IIActive
Tryptic Soy Broth K844541
FDA 510(k)
Class IActive
Vitek 2 Strptococcus Ampicillin K112075
FDA 510(k)
Class IIActive
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) K214023
FDA 510(k)
Class IIActive
VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) K222378
FDA 510(k)
Class IIActive
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) K234000
FDA 510(k)
Class IIActive
Vitek 2 Gram Positive Telithromycin For Streptococcus Pneumoniae K053186
FDA 510(k)
Class IIActive
Vidas H. Pylori Igg (hpy) Assay, Model 30 192 K001460
FDA 510(k)
Class IActive
Kliger Iron Agar K844520
FDA 510(k)
Class IActive
Thayer-Martin, Modified K830061
FDA 510(k)
Class IIActive
Simmons Citrate Agar K844532
FDA 510(k)
Class IActive
Vitek Ms DEN130013
FDA 510(k)
Class IIActive
Vitek 2 Gram Positive Trimethoprim/Sulfamethoxazole K050976
FDA 510(k)
Class IIActive
Macconkey Agar K830071
FDA 510(k)
Class IActive
Vitek 2 Gram Negative Piperacillin K073083
FDA 510(k)
Class IIActive
Phenol Red Broth W/Carbohydrates K844539
FDA 510(k)
Class IActive
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance K260282
FDA 510(k)
Class IIActive
Nutrient Agar K830068
FDA 510(k)
Class IActive
Chocolate Mueller Hinton Agar K871097
FDA 510(k)
Class IIActive

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