Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
BioCLIA Allergy Reagent Kit, Fx24
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06924030413026
- Basic UDI-DI Code
- B-06924030413026
- Reference
- MY01690
- 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 Fx24 (Chemiluminescent Microparticle Immunoassay) is used for in vitro quantitative determination of IgE antibodies specific to Hazel nut (F17), Shrimp (F24), Kiwi (F84), Banana (F92) 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 F17, F24, F84, F92. 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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