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Biomérieux

United States·US-MF-000011802

Last updated May 24, 2026

Part of Biomerieux Sa

What Biomérieux makes

Biomérieux produces general-microorganism antimicrobial susceptibility culture medium IVD devices, including the VITEK® 2 AST-N459, VITEK® 2 AST-N447, VITEK® 2 AST-N455, VITEK® 2 AST-N478, VITEK® 2 AST-N451, VITEK® 2 AST-N440, VITEK® 2 AST-N386, VITEK® 2 AST-N404, VITEK® 2 AST-N460, VITEK® 2 AST-XN36, VITEK® 2 AST-P663, and VITEK® 2 AST-P670.

The company's portfolio is regulated and listed in eudamed and fda_510k, with devices classified as Class B, Class I, and Class II. Biomérieux is based in the US.

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

Frequently asked questions

What medical devices does Biomérieux manufacture?

Biomérieux produces general-microorganism antimicrobial susceptibility culture medium IVD devices, including the VITEK® 2 AST-N459, VITEK® 2 AST-N447, VITEK® 2 AST-N455, VITEK® 2 AST-N478, VITEK® 2 AST-N451, VITEK® 2 AST-N440, VITEK® 2 AST-N386, VITEK® 2 AST-N404, VITEK® 2 AST-N460, VITEK® 2 AST-XN36, VITEK® 2 AST-P663, and VITEK® 2 AST-P670.

Where is Biomérieux based?

Biomérieux is based in the US, where it manufactures and distributes its medical devices for clinical laboratory use.

Which regulatory registries list Biomérieux's devices?

Biomérieux's devices are listed in eudamed and fda_510k regulatory registries, ensuring compliance with international and US regulatory requirements for medical devices.

How are Biomérieux's devices classified?

Biomérieux's devices are classified as Class B, Class I, and Class II, which indicates varying levels of regulatory control based on the potential risks associated with each device type.

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

Information

Country
United States
Address
100, Rodolphe Street, Durham, United States
Website
biomerieux.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
—
PRRC Contact
Michael LUCIDO
EUDAMED SRN
US-MF-000011802
FDA FEI Number
—
DUNS Number
—

Catalogue (64)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
Vitek® 2 Ast-N475 543564
EUDAMED
Class BActive
Vitek® 2 Ast-N481 543655
EUDAMED
Class BActive
Vitek® 2 Ast-N468 543541
EUDAMED
Class BActive
Vitek® 2 Ast-N470 543550
EUDAMED
Class BActive
Vitek® 2 Ast-N466 543532
EUDAMED
Class BActive
Vitek® 2 Ast-N446 543376
EUDAMED
Class BActive
Vitek® 2 Ast-N467 543540
EUDAMED
Class BActive
Vitek® 2 Ast-N448 543397
EUDAMED
Class BActive
Vitek® 2 Ast-N436 543273
EUDAMED
Class BActive
ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD K232395
FDA 510(k)
Class IIActive
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) K260281
FDA 510(k)
Class IIActive
Etest Tobramycin 0.016-256 Ug/Ml And 0.064-1024 Ug/Ml K102668
FDA 510(k)
Class IIActive
VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II K141133
FDA 510(k)
Class IActive
ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) K250856
FDA 510(k)
Class IIActive

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