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ADVIA Centaur® CKMB Diluent
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 10326496Model IVDR_67_TTN_DUB-C_C_KIT_CKMB
Identity
- Trade Name
- ADVIA Centaur® CKMB EUDAMEDFDA UDIADVIA Centaur® CKMB Diluent FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDICreatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_C_KIT_CKMB EUDAMEDCKMB Dil.RP (2PK) - CENTAUR - CAL - 2x5mL FDA UDICKMB Mass - CENTAUR - RGT - 500 tests FDA UDI
- Model / Reference
- 10326496 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_C_KIT_CKMB EUDAMED10309951 FDA UDI
- Description
- CKMB Dil.RP (2PK) - CENTAUR - CAL - 2x5mL FDA UDICKMB Mass - CENTAUR - RGT - 500 tests FDA UDI
Identifiers
- Catalog Number
- 110323 FDA UDI110774 FDA UDI
- Primary DI / UDI-DI
- 00630414177441 EUDAMEDFDA UDI00630414175324 FDA UDI
- Basic UDI-DI
- 0405686901804VS EUDAMED
- Unit of Use DI
- 00630414003627 EUDAMED
- 510(k) Number
- K962126 FDA UDI
- FDA Product Code
- JHS FDA UDI
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED
- GMDN Term
- Buffered sample diluent IVD FDA UDICreatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1215 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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: Buffered sample diluent IVD
ADVIA Centaur® CKMB Diluent by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K962126 also covers:
- ADVIA Centaur® CKMB — Siemens Healthcare Diagnostics
- ADVIA Centaur® CKMB MCM — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
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
- Siemens Healthcare Diagnostics
Sources (3)
- FDA UDI a261bc77-cf47-491b-8412-e09428f94166 37 fields · synced Jul 21, 2026
- FDA UDI c2deb1ea-5801-4e75-83af-dbe90adc2e2a 37 fields · synced May 30, 2026
- EUDAMED 42f680e2-e81b-4547-b685-0d2ec73cbdf0 61 fields · synced Jul 21, 2026