Immunoglobulin M
Basic Information
- Primary DI
- 16438153819384
- Basic UDI-DI Code
- 6438153BU00110B9
- Reference
- 981938
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Thermo Fisher Scientific Oy
Additional Description
For in vitro diagnostic use in the quantitative determination of immunoglobulin M (IgM) concentration in human serum and plasma with the automated procedures of Thermo Scientificโข Indikoโข and Konelabโข analyzers. The Immunoglobulin M (IgM) test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of primary viral infections and bloodstream infection with parasites including malaria, in patients. Furthermore, the Immunoglobulin tests in general are indicated to be used in conjunction with clinical evaluation for aid to diagnosis of immune deficiencies, autoimmune diseases as well as infections, in patients.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102010107 | IMMUNOGLOBULIN M |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).