Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
BioCLIA Allergy Reagent Kit, Gx1
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06924030413330
- Basic UDI-DI Code
- B-06924030413330
- Reference
- MY01693
- 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 Gx1 (Chemiluminescent Microparticle Immunoassay) is used for in vitro quantitative determination of IgE antibodies specific to Dactylis glomerata (G3), Festuca elatior (G4), Lolium perenne (G5), Phleum pretense (G6), Poa pratensis (G8) 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 G3, G4, G5, G6, G8. The test results are to be used in conjunction with clinical findings and other laboratory tests.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01020203 | IMMUNOGLOBULIN E - MONOTEST/MONORESULT - MULTI AG |
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