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Sign in to claim this brandWhat 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
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Michael LUCIDO
- EUDAMED SRN
- US-MF-000011802
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (64)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vitek® 2 Ast-N459 | 543505 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N447 | 543388 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N455 | 543496 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N478 | 543628 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N451 | 543462 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N440 | 543324 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N386 | 542466 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N404 | 542727 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N460 | 543506 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-Xn36 | 543543 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-P663 | 542707 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-P670 | 543539 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N454 | 543495 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-Xn39 | 543656 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N453 | 543477 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N438 | 543321 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N442 | 543340 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N469 | 543542 | EUDAMED | Class B | Active |
| Virtual, Kb Update, V2s 10.1 | 424731 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N461 | 543508 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N416 | 542943 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-Xn40 | 543660 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N424 | 543116 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N402 | 542705 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N480 | 543654 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N477 | 543611 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N441 | 543342 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N471 | 543551 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N367 | 8310305 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N458 | 543504 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N456 | 543497 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-Xn35 | 543507 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N445 | 543380 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-P671 | 543572 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N444 | 543375 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N449 | 543436 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N421 | 543081 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N457 | 543498 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-Xn38 | 543644 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N395 | 542603 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N476 | 543571 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N437 | 543320 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N439 | 543323 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-St03 | 8309563 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N462 | 543528 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N403 | 542706 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-P673 | 543653 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N450 | 543461 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-Gn09 | 8308211 | EUDAMED | Class B | Active |
| Vitek® 2 Ast-N422 | 543082 | EUDAMED | Class B | Active |
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