Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Sars-CoV-2 & RSV & Influenza A+B Antigen Combo Rapid Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06974238910179
- Basic UDI-DI Code
- B-06974238910179
- Reference
- HSRI076G
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou Immuno Biotech Co., Ltd
Additional Description
The Sars-CoV-2 & RSV & Influenza A+B Antigen Combo Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Sars-CoV-2, Respiratory Syncytial Virus and Influenza A/B antigens in human nasopharyngeal swab specimen in individuals who are suspected of respiratory viral infection consistent with COVID-19, RSV and/or flu.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040505 | RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS |
| W0105040504 | INFLUENZA & PARA INFLUENZA - NA REAGENTS |
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
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