Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
GENEDIAN
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-RA007UP
- Basic UDI-DI Code
- B-RA007UP
- Reference
- L111-10125
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou DIAN Biotechnology Co., Ltd.
Additional Description
The kit is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in nasal swab specimen to aid in the diagnosis of COVID-19 viral infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
| W0105099099 | VIROLOGY - RT & POC - OTHER |
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