Eu Ivdd
Eu Ivd Self Testing
On The Market
🇫🇮 Finland
Biocard™ Celiac Home
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06416842928015
- Basic UDI-DI Code
- B-06416842928015
- Reference
- 3-028-200
- Device Types
-
Single use Sterile
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Labsystems Diagnostics Oy
Additional Description
Biocard™ Celiac Test is a rapid, simple and reliable home test for the detection of celiac disease associated IgA autoantibodies from fingertip blood sample.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100602 | TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | C-02-1172-802-22 | Eurofins Electric & Electronics Finland Oy | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Self Testing) and regulation (EU IVDD).
CERA-CHEK™ Lactate Measuring System
Device
EU IVDD
·
Eu Ivd Self Testing
·GC MEDIS Corp.·On the market·2 countries
CERA-CHEK™ Lactate Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·GC MEDIS Corp.·On the market·2 countries
BGI
Device
EU IVDD
·
Eu Ivd Self Testing
·BGI EUROPE A/S·On the market
Lactate Pro 2 (LT-1730)
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market
Lactate Pro 2 Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market
Lactate Pro 2 Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market