Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
VIROLOGY - RT & POC - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06970664751492
- Basic UDI-DI Code
- B-06970664751492
- Reference
- 25Tests/kit
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Additional Description
COVID-19 Neutralization Rapid Test Kit （FIA）is a solid phase immunofluorescent assay that is intended for the quantitative direct detection of total neutralizing antibodies to 2019 novel coronavirus (SARS-CoV-2) in human serum or plasma or whole blood. It is intended for use for identifying individuals with an adaptive immune response to COVID-19, indicating recent or prior infection or getting immune response to COVID-19 after being injected with vaccine to COVID-19.It should not be used to diagnose acute COVID-19 infection. Testing is only limited to professional laboratories.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
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