Identity
- Trade Name
- VITEK®2 FDA UDI
- Generic Name
- Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI
- Device Name
- VITEK®2 XL is an automated system that performs large volumes of bacterial ID & AST testings FDA UDI
- Model / Reference
- 27227R FDA UDI
- Description
- VITEK®2 XL is an automated system that performs large volumes of bacterial ID & AST testings FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026206789 FDA UDI
- FDA Product Code
- LON FDA UDI
- GMDN Term
- Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1645 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Microorganism identification/antimicrobial-susceptibility analyser IVD
Vitek®2 by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Microorganism identification/antimicrobial-susceptibility analyser IVD.
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Cleared under the same submission
N50510 also covers:
- SALINE SOLUTION — BIOMERIEUX , INC.
- SMART CARRIER STATION — BIOMERIEUX , INC.
- VITEK — BIOMERIEUX , INC.
- VITEK® 2 AST-GN48 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN66 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN68 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN69 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN70 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN72 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN73 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN74 — BIOMERIEUX , INC.
- VITEK® 2 AST-GN75 — BIOMERIEUX , INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (1)
- FDA UDI 518f74ee-0a64-4782-b1d6-b5bf5829410c 35 fields · synced Jun 6, 2026