Specific IgE ELISA (XL Kit)
Basic Information
- Primary DI
- 04260153756421
- Basic UDI-DI Code
- B-04260153756421
- Reference
- 36080000
- 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 ELISAs are Enzyme Immunoassays based on paper discs. They can only be used in combination with Gold Standard Diagnostics Kassels Allergen Discs (div). The combination of specific IgE Kit and allergen discs is intended for the detection and the quantitative determination of circulating 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 |
|---|---|
| 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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