Identity
- Trade Name
- VITEK® MS FDA UDI
- Generic Name
- Microbial identification mass spectrometry system IVD FDA UDI
- Device Name
- Cassette docking station needed for preparing sample loading in the VITEK 2 system FDA UDI
- Model / Reference
- 27210 FDA UDI
- Description
- Cassette docking station needed for preparing sample loading in the VITEK 2 system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026328573 FDA UDI
- 510(k) Number
- DEN130013 FDA UDI
- FDA Product Code
- PEX FDA UDI
- GMDN Term
- Microbial identification mass spectrometry system IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3361 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: Microbial identification mass spectrometry system IVD
Vitek® Ms by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microbial identification mass spectrometry system IVD.
- MBT-CA System BD — Bruker Daltonik GmbH · Class II
- MALDI Biotyper CA System — Bruker Daltonik GmbH · Class II
- MALDI Biotyper-BD sirius one CA System — Bruker Daltonik GmbH · Class II
- MALDI Biotyper-BD sirius CA System — Bruker Daltonik GmbH · Class II
- MALDI Biotyper - smart CA — Bruker Daltonik GmbH · Class II
- MBT Pilot System - US IVD — Bruker Daltonik GmbH · Class II
- MALDI Biotyper sirius CA System — Bruker Daltonik GmbH · Class II
- MBT Galaxy System - US IVD — Bruker Daltonik GmbH · Class II
Cleared under the same submission
DEN130013 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (1)
- FDA UDI abfcd6b1-c566-4ddf-9b7c-c10c99c94637 35 fields · synced Jun 6, 2026