Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
BioCLIA Allergy Reagent Kit, F423
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06924030409579
- Basic UDI-DI Code
- B-06924030409579
- Reference
- MY01214
- 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, F423 is an in vitro quantitative assay for the determination of specific IgE to Ara h 2, Peanut (F423) 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 Ara h 2, Peanut (F423) in conjunction with other clinical findings, and is to be used in clinical laboratories.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01020202 | IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT |
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