BioCLIA Allergy Reagent Kit, F422
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- 06924030413453
- Basic UDI-DI Code
- B-06924030413453
- Reference
- MY01701
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- HOB Biotech Group Corp., Ltd.
Additional Description
BioCLIA sIgE F422 (Chemiluminescent Microparticle Immunoassay) is used for in vitro quantitative determination of IgE antibodies specific to rAra h 1 (Peanut conarachin) (Arachis hypogaea, F422) in human serum by the chemiluminescent immunoassay method. It is intended for in vitro diagnostic use to aid in the clinical evaluation of IgEmediated allergic disorders specific to rAra h 1 (Peanut conarachin). The test results are to be used in conjunction with clinical findings and other laboratory tests.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01020202 | IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).