Basic Information
- Primary DI
- 05204309071050
- Basic UDI-DI Code
- 5204309000028NY
- Reference
- 1418-0787
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Medicon Hellas SA
Additional Description
Reagents for In Vitro quantitative automated determination of the concentration of Immunoglobulin A – IgA in samples of human serum or plasma from the general patient population. Measurements of IgA are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians, as an aid for the assessment of immune status. This product has been packed for use with BECKMAN COULTER AU series chemistry analyzers (AU600, AU600IVD, AU400, AU640, AU2700, AU5400, AU480, and AU680). For in vitro diagnostic use only by trained laboratory professionals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102010101 | IMMUNOGLOBULIN A |
Available In Countries
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The Basic UDI-DI associated with this device has 4 devices in total. Below are some other devices sharing the same Basic UDI-DI.
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).