Identity
- Trade Name
- ADVIA Centaur® CKMB MCM FDA UDI
- Generic Name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, control FDA UDI
- Device Name
- CK-MB 2 Master Curve Material - CENTAUR - CONS FDA UDI
- Model / Reference
- 10309782 FDA UDI
- Description
- CK-MB 2 Master Curve Material - CENTAUR - CONS FDA UDI
Identifiers
- Catalog Number
- 105805 FDA UDI
- Primary DI / UDI-DI
- 00630414056098 FDA UDI
- 510(k) Number
- K962126 FDA UDI
- FDA Product Code
- CDD FDA UDI
- GMDN Term
- Creatine kinase myocardial isoenzyme (CKMB) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1810 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: Creatine kinase myocardial isoenzyme (CKMB) IVD, control
ADVIA Centaur® CKMB MCM by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Creatine kinase myocardial isoenzyme (CKMB) IVD, control.
- ARCHITECT — Abbott Ireland Diagnostics · Class I
- i-STAT — Abbott Point of Care Inc. · Class I
- POINTE SCIENTIFIC CK-MB Controls — POINTE SCIENTIFIC, INC. · Class I
- i-STAT — Abbott Point of Care Inc. · Class I
- CK-MB CONTROL — Randox Laboratories, Ltd. · Class II
- i-STAT — Abbott Point of Care Inc. · Class I
- i-STAT — Abbott Point of Care Inc. · Class I
- Alinity — Abbott Ireland Diagnostics · Class I
Cleared under the same submission
K962126 also covers:
- ADVIA Centaur® CKMB — Siemens Healthcare Diagnostics
- ADVIA Centaur® CKMB Diluent — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems CKMB Calibrator — Siemens Healthcare Diagnostics
- Atellica IM CKMB — Siemens Healthcare Diagnostics
- Atellica IM CKMB — Siemens Healthcare Diagnostics
- Atellica IM CKMB — Siemens Healthcare Diagnostics
- Atellica IM CKMB Calibrator — Siemens Healthcare Diagnostics
- Atellica IM CKMB DIL — Siemens Healthcare Diagnostics
- Atellica IM CKMB MCM — Siemens Healthcare Diagnostics
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 a8e04610-ee32-4790-b923-c04c11c444ae 37 fields · synced Jun 8, 2026