Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
VIROLOGY - RT & POC - OTHER
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06970664751577
- Basic UDI-DI Code
- B-06970664751577
- Reference
- 5 Tests/kit
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Additional Description
COVID-19 Antigen Rapid Test Kit is a solid phase immunochromatographic assay for the in vitro qualitative detection of nuleocapsid protein antigen from 2019 Novel Coronavirus in human nasal specimen from symptomatic individuals who are suspected of being infected with COVID-19. Children under 18 years of age and adults over 65 years of age should be assisted by an adult. This test kit provides only a preliminary test result for COVID-19 infection as a clinically assisted diagnosis.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-238/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
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