CK (IFCC)
Basic Information
- Primary DI
- 16438153818295
- Basic UDI-DI Code
- 6438153BU00159C7
- Reference
- 981829
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Thermo Fisher Scientific Oy
Additional Description
INTENDED PURPOSE / INTENDED USE For in vitro diagnostic use in the quantitative determination of creatine kinase (ATP: Creatine N-Phosphotransferase (CK), EC 2.7.3.2) activity in human serum and plasma with the automated procedures of Thermo Scientificโข Indikoโข and Konelabโข analyzers. The CK test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of myopathies and muscle damages, caused for example by inflammation, toxic or drug-induced injuries and necrosis of skeletal muscle (e.g. rhabdomyolysis), in patients.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010113 | CREATINE KINASE - TOTAL |
Available In Countries
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Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).