Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
2-IN-1 COVID-19 Antigen Rapid Test Device (swab)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06971792050822
- Basic UDI-DI Code
- B-06971792050822
- Reference
- K791416D
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou Realy Tech Co.,Ltd.
Additional Description
The 2-IN-1 COVID-19 Antigen Rapid Test Device(swab) is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens in Nasopharyngeal swab and Oropharyngeal swab, using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the novel coronavirus antigen. It will provide information for clinical doctors to prescribe correct medications.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
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