Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
FLU A&B &COVID-19 & RSV & Adeno Antigen Combo Test Cassette
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06970895474238
- Basic UDI-DI Code
- B-06970895474238
- Reference
- R224T020B0C0
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
Additional Description
The FLU A&B & COVID-19 & RSV & Adeno Antigen Combo Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of influenza A (FLU A), influenza B (FLU B), COVID-19 (SARS-CoV-2), respiratory syncytial virus(RSV) and adenovirus (Adeno) antigen in nasopharyngeal swab specimens. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, COVID-19, respiratory syncytial virus and adenovirus viral infections in humans in conjunction with clinical and epidemiological risk factors.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
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