immunoLINE IgE Inhalation KW3
Basic Information
- Primary DI
- 04260153751280
- Basic UDI-DI Code
- B-04260153751280
- Reference
- ILE-LBL37
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Gold Standard Diagnostics Kassel GmbH
Additional Description
immunoLINE IgE Lineblots are Enzyme Immunoassays based on Nitrocellulose Strips which are intended for the detection and the quantitative determination of human IgE antibodies directed towards various specified allergens in serum and plasma. The tests are used as an aid in the diagnostic evaluation of patients with proven or suspected allergic disease. Specific IgE laboratory results can never be the only base of a medical report. The patient history and further tests like skin tests and - if possible - provocation tests have additionally to be taken into account. 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 |
|---|---|
| W01020205 | IMMUNOGLOBULIN E - SCREEN |
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).