Eu Ivdd
Eu Ivd General
On The Market
๐ง๐ช Belgium
BlueWell Deamidated Gliadin IgA ELISA
Devices (same UDI-DI)
1
Certificates
0
Countries
18
Notified Bodies
0
Basic Information
- Primary DI
- 05425023680193
- Basic UDI-DI Code
- B-05425023680193
- Reference
- DGLA02-96
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- D-tek s.a.
Additional Description
BlueWell Celiac kits are ELISA kits allowing the quantitative detection, in human serum, of specific IgG or IgA auto-antibodies in the context of a Celiac disease diagnostic. The tests are intended for a large, routine population. The kits are strictly reserved for laboratory professional use, by trained staff. The kits could be processed manually or by means of standard ELISA automates.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100602 | TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐น Italy
๐ฑ๐บ Luxembourg
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSUREโข HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSUREโข Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSUREโข HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries