Identity
- Trade Name
- VITEK® MS SOFTWARE v1.1 FDA UDI
- Generic Name
- Microbial identification mass spectrometry system IVD FDA UDI
- Device Name
- The VITEK® MS Software is a computer application which supports the microbiology laboratory workflow for the VITEK® MS Systems. FDA UDI
- Model / Reference
- VITEK MS SW V1.1 FDA UDI
- Description
- The VITEK® MS Software is a computer application which supports the microbiology laboratory workflow for the VITEK® MS Systems. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026621698 FDA UDI
- FDA Product Code
- PEX FDA UDIQBN FDA UDI
- GMDN Term
- Microbial identification mass spectrometry system IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3361 FDA UDI866.3378 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Microbial identification mass spectrometry system IVD
VITEK® MS SOFTWARE v1.1 by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162950 also covers:
K181412 also covers:
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 4ee43db8-89b8-4241-b67c-e39f0606c470 34 fields · synced May 30, 2026