IgA
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records โ and cites every one.
Free to try ยท every answer cites its records
Basic Information
- Primary DI
- 15099590011574
- Basic UDI-DI Code
- 150995901OSR61171SX
- Reference
- OSR61171
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Beckman Coulter Inc.
Additional Description
IgA reagent is an in vitro diagnostic medical device intended to be used by healthcare professionals for the quantitative immunoturbidimetric measurement of Immunoglobulin A (IgA) in human serum and plasma using the automated Beckman Coulter AU/DxC AU analyzers. Measurement of IgA is intended to be used as an aid to the diagnosis of infection or as an aid to the diagnosis of IgA deficiency. This reagent is not intended to diagnose complete IgA deficiency or complete IgA subtype deficiency prior to transfusions.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102010101 | IMMUNOGLOBULIN A |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).