Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Flu A/B & COVID-19 Ag Combo Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06933260208951
- Basic UDI-DI Code
- B-06933260208951
- Reference
- BT1781
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
Additional Description
Flu A/B & COVID-19 Ag Combo Test is a colloidal gold immunochromatography intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasal swab specimens obtained from individuals, who are suspected of COVID-19, influenza A or influenza B infection. Clinical signs and syptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040699 | VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER |
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