Eu Ivdd
Eu Ivd General
On The Market
🇩🇪 Germany
ALLERGENE SPECIFIC IGG
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-ILE-SCG2313Q
- Basic UDI-DI Code
- B-ILE-SCG2313Q
- Reference
- ILE-SCG231
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Gold Standard Diagnostics Kassel GmbH
Additional Description
Food Intolerance IgG4 Screen ELISAs are Enzyme Immunoassays based on Microtiter Plates which are intended for the detection and the quantitative determination of human IgG4 antibodies directed towards various specified antigens in serum and plasma. The tests are used to screen patients for various non-IgE-induced food intolerances. The tests are designed for in vitro diagnostic use only. They are intended for manual performance by trained professional users.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01020208 | ALLERGENE SPECIFIC IGG |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | SX 1701347-1 | TÜV Rheinland LGA Products GmbH |
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
extendSURE™ 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
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries