Eu Ivdd
Eu Ivd General
On The Market
🇩🇪 Germany
SPECIFIC PROTEINS - OTHER
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 04260153751334
- Basic UDI-DI Code
- B-04260153751334
- Reference
- 36061000
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Gold Standard Diagnostics Kassel GmbH
Additional Description
ECP (Eosinophil Cationic protein) ELISAs are Enzyme Immunoassays based on Microtiter Plates which are intended for the quantitative determination human Eosinophil Cationic Protein in serum. The tests are used as aid in diagnostics or various allergic reactions. 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 |
|---|---|
| W0102019099 | SPECIFIC PROTEINS - 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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