Identity
- Trade Name
- ADVIA Centaur® CpS MCM FDA UDI
- Generic Name
- C-peptide IVD, control FDA UDI
- Device Name
- C-Peptide S Master Curve Material Kit - CENTAUR - CONS FDA UDI
- Model / Reference
- 10310446 FDA UDI
- Description
- C-Peptide S Master Curve Material Kit - CENTAUR - CONS FDA UDI
Identifiers
- Catalog Number
- 129023 FDA UDI
- Primary DI / UDI-DI
- 00630414464022 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- C-peptide IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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
Category: C-peptide IVD, control
ADVIA Centaur® CpS MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Alinity — Abbott · Class I
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- AIA-PACK C-Peptide Control Set — Tosoh Corp. · Class I
- Atellica IM CpS MCM — Siemens Healthcare Diagnostics · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI bd3dc93d-47d9-4b69-a23a-4accbae8ff41 36 fields · synced May 30, 2026