Eu Ivdd
Eu Ivd General
On The Market
🇩🇪 Germany
ALLERGY TESTS - OTHER
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-ILR-E01XA
- Basic UDI-DI Code
- B-ILR-E01XA
- Reference
- ILR-E01
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Gold Standard Diagnostics Kassel GmbH
Additional Description
Specific IgE I-125 Tracer are anti-human IgE antibodies conjugated to iodine-125 in a buffered protein solution. The products are designed for in vitro diagnostic use. They are intended for manual performance by trained professional users.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01020299 | ALLERGY TESTS - OTHER |
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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