Eu Ivdd
Eu Ivd General
On The Market
🇩🇪 Germany
Kontrollallergenscheiben für Spez. IgE ELISA
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 04260153756438
- Basic UDI-DI Code
- B-04260153756438
- Reference
- 37227001
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Gold Standard Diagnostics Kassel GmbH
Additional Description
Positivkontrolle für Spez. IgE ELISA is a control serum suitable for checking the accuracy of the Gold Standard Diagnostics Kassel Specific IgE kits. It can only be used in combination with Gold Standard Diagnostics Kassels Specific IgE ELISA Kits. 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 |
|---|---|
| W01020202 | IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT |
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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