Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge EUDAMEDFDA UDI
- Generic Name
- Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- IVDR_67_GLA_DUB-C_C_REAG_Mass Creatine Kinase MB EUDAMEDMass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 80 tests FDA UDI
- Model / Reference
- 10444895 EUDAMEDFDA UDIIVDR_67_GLA_DUB-C_C_REAG_Mass Creatine Kinase MB EUDAMED
- Description
- Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 80 tests FDA UDI
Identifiers
- Catalog Number
- RF520 FDA UDI
- Primary DI / UDI-DI
- 00842768013898 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901279VT EUDAMED
- Unit of Use DI
- 00630414003863 EUDAMED
- 510(k) Number
- K970343 FDA UDI
- FDA Product Code
- JHY FDA UDI
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED
- GMDN Term
- Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA) 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
Yes
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
K970343 also covers:
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
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI c9fa7e5c-2b4f-4105-b2ec-a3044d95299e 37 fields · synced Jul 31, 2026
- EUDAMED d58d6509-b14b-4629-9414-7e5c2899eaaf 61 fields · synced Jul 31, 2026