Identity
- Trade Name
- VITEK®2 Compact FDA UDI
- Generic Name
- Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI
- Device Name
- VITEK® 2 COMPACT 60 is an automated system that performs bacterial ID & AST. A total of 60 ID and/or AST cards can be processed simultaneously per run. FDA UDI
- Model / Reference
- 27560R FDA UDI
- Description
- VITEK® 2 COMPACT 60 is an automated system that performs bacterial ID & AST. A total of 60 ID and/or AST cards can be processed simultaneously per run. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026147501 FDA UDI
- 510(k) Number
- K050002 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 Compact by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 3df65da8-b5a1-438d-b8d5-5784fe64b068 35 fields · synced May 31, 2026