Eu Ivdd
Eu Ivd General
On The Market
🇩🇪 Germany
Gesamt IgE
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 04260153751310
- Basic UDI-DI Code
- B-04260153751310
- Reference
- 36090000
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Gold Standard Diagnostics Kassel GmbH
Additional Description
Gesamt IgE ELISAs are Enzyme Immunoassays based on Microtiter Plates which are intended for the quantitative determination of circulating total IgE in human serum and plasma. The tests are used as an interpretation aid in diagnostics. 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 |
|---|---|
| W01020201 | IMMUNOGLOBULIN E - TOTAL |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | SX 1701347-1 | TÜV Rheinland LGA Products GmbH |
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