Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
CORONAVIRUS [obsolete from 2025-01-01]
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 16974198355017
- Basic UDI-DI Code
- B-16974198355017
- Reference
- nCoVAG
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou Higene Biotechnology Co.,LTD.
Additional Description
The SARS-CoV-2 Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swab and oropharyngeal swab from individuals who are suspected of COVID-19 by their healthcare provider.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
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