BlueDot Celiac IgA
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Basic Information
- Primary DI
- 05425023680421
- Basic UDI-DI Code
- B-05425023680421
- Reference
- ENDA-24
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- D-tek s.a.
Additional Description
BlueDot Celiac kits are immunodot kits allowing the detection, in human serum, of specific IgG or IgA auto-antibodies in the context of a Celiac disease diagnostic. BlueDot Celiac kits are intended to be used as confirmatory tests following other screening enzyme immunoassay (EIA), considered as reference method for anti-Gliadin or anti-tTG detection. The tests are intended for a large, routine population. The kits are strictly reserved for professional use, by trained staff. The kits must be processed manually on a rotary shaker platform.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100602 | TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | BE24/00000082 | SGS United Kingdom Limited |
Available In Countries
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