Identity
- Trade Name
- VITEK® MS FA EUDAMEDFDA UDI
- Generic Name
- Microbial identification mass spectrometry system IVD FDA UDI
- Device Name
- VITEK® MS FA EUDAMEDVITEK ® MS - FA is used to pretreat yeasts to facilitate their identification according to the MALDI - TOF method. It is used exclusively with the VITEK ® MS instrument. FDA UDI
- Model / Reference
- 8309836 EUDAMEDVITEK® MS FA FDA UDI
- Description
- VITEK ® MS - FA is used to pretreat yeasts to facilitate their identification according to the MALDI - TOF method. It is used exclusively with the VITEK ® MS instrument. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026555559 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000889UU EUDAMED
- 510(k) Number
- DEN130013 FDA UDI
- FDA Product Code
- PEX FDA UDI
- EMDN Code
- W02039085 VARIOUS MICROBIOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Microbial identification mass spectrometry system IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3361 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Microbial identification mass spectrometry system IVD
Vitek® Ms Fa by Biomerieux , Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 2a41b005-cca0-4c83-81c4-da2b443a60ec 35 fields · synced Jun 18, 2026
- EUDAMED 051605b6-9f87-40e5-a455-b5a61c1a562a 61 fields · synced Jun 18, 2026