Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
COVID-19 Antigen Rapid Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-ICOV05FD
- Basic UDI-DI Code
- B-ICOV05FD
- Reference
- ICOV5002-B001;ICOV5002-B005;ICOV5002-B025
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou Clongene Biotech Co., Ltd.
Additional Description
The COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swab, nasal swab or oropharyngeal swab from individuals who are suspected of COVID-19 by their healthcare provider.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
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