Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
BioCLIA Allergy Reagent Kit, D201
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06924030412692
- Basic UDI-DI Code
- B-06924030412692
- Reference
- MY01694
- 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 D201 (Chemiluminescent Microparticle Immunoassay) is used for in vitro quantitative determination of IgE antibodies specific to House dust mite (Blomia tropicalis, D201) in human serum by the chemiluminescent immunoassay method. It is intended for in vitro diagnostic use to aid in the clinical evaluation of IgE-mediated allergic disorders specific to Blomia tropicalis. 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 |
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