Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06419587020808
- Basic UDI-DI Code
- B-06419587020808
- Reference
- 602080
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Biohit Oyj
Additional Description
BIOHIT Celiac quick test is a qualitative in vitro immunochromatographic test aiding in diagnosis of celiac disease by detecting antibodies (IgA/IgG/IgM) against human tissue transglutaminase in whole blood, plasma or serum samples. The test is conducted manually or semi-automatically and is intended to be used by healthcare professionals, either in a laboratory-based or point of care (POC) setting. Package size: 50 tests per kit.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100601 | TISSUE TRANSGLUTAMINASE ANTIBODIES |
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