Identity
- Trade Name
- VITEK® MS MOULD KIT EUDAMEDFDA UDI
- Generic Name
- Microbial identification mass spectrometry system IVD FDA UDI
- Device Name
- VITEK® MS MOULD KIT EUDAMEDThe VITEK® MS MOULD KIT provides the reagents and consumables needed to process samples by protein extraction and inactivation for mould identification from agar plates by the VITEK® MS System. FDA UDI
- Model / Reference
- 415680 EUDAMEDVITEK® MS MOULD KIT FDA UDI
- Description
- The VITEK® MS MOULD KIT provides the reagents and consumables needed to process samples by protein extraction and inactivation for mould identification from agar plates by the VITEK® MS System. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026437282 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000891UF EUDAMED
- 510(k) Number
- K162950 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
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Microbial identification mass spectrometry system IVD
Vitek® Ms Mould Kit by Biomerieux , Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (2)
- FDA UDI f9a4a023-4d79-469b-bac7-26af288f1466 35 fields · synced Jul 13, 2026
- EUDAMED 3457568f-dc7c-4cbf-a4b3-841d6976c042 61 fields · synced Jul 13, 2026