BioLINE Allergy Reagent Kit
Basic Information
- Primary DI
- 06924030412586
- Basic UDI-DI Code
- B-06924030412586
- Reference
- MB00280
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- HOB Biotech Group Corp., Ltd.
Additional Description
BioLINE Allergy Reagent Kit (B), is an in vitro semi-quantitative assay for the determination of allergy specific IgE to multiple allergens. Allergens include Dermatophagoides pteronyssinus/ Dermatophagoides farinae/ Cat dander/ Dog dander/ Egg white/ Peanut/ Soybean/ Hazel nut/ Milk/ Pistachio nuts/ Crab/ Shrimp/ European ash/ Fish/ Wheat/ Egg yolk/ Cockroach, German / Penicillium chrysogenum/ Aspergillus fumigatus / Alternaria alternata/ London plane/ Elm/ Common ragweed/ Japanese Hop / Mugwort. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories for professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01020204 | IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).