Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
BioCLIA Allergy Reagent Kit, Fx5
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06924030410513
- Basic UDI-DI Code
- B-06924030410513
- Reference
- MY01307
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- HOB Biotech Group Corp., Ltd.
Additional Description
BioCLIA Allergy Reagent Kit, Fx5 is an in vitro qualitative assay for the determination of mixed specific IgE to Egg white (F1), Milk (F2), Fish(cod) (F3), Wheat (F4), Peanut (F13), Soybean (F14) in human serum via chemiluminescent immunoassay method on the fully automatic BioCLIA instrument. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders specific to F1, F2, F3, F4, F13, F14 in conjunction with other clinical findings, and is to be used in clinical laboratories.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01020203 | IMMUNOGLOBULIN E - MONOTEST/MONORESULT - MULTI AG |
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