Identity
- Trade Name
- ADVIA Centaur® VANC MCM FDA UDI
- Generic Name
- Vancomycin therapeutic drug monitoring IVD, control FDA UDI
- Device Name
- Vancomycin Master Curve Material Set - CENTAUR - CONS FDA UDI
- Model / Reference
- 10311613 FDA UDI
- Description
- Vancomycin Master Curve Material Set - CENTAUR - CONS FDA UDI
Identifiers
- Catalog Number
- 672362000 FDA UDI
- Primary DI / UDI-DI
- 00630414126111 FDA UDI
- 510(k) Number
- K951059 FDA UDI
- FDA Product Code
- LEH FDA UDI
- GMDN Term
- Vancomycin therapeutic drug monitoring IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3950 FDA UDI
- Commercial Distribution
- Not 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ADVIA Centaur® VANC MCM by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 933514bb-2615-4397-821c-a785736f8ba3 38 fields · synced Jun 1, 2026