Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
FLU A&B &COVID-19 & RSV & Adeno & MP Antigen Combo Test Cassette
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06970895474245
- Basic UDI-DI Code
- B-06970895474245
- Reference
- R225T020B0C0
- 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 & MP 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), adenovirus (Adeno) and mycoplasma pneumoniae (MP) 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, adenovirus viral and mycoplasma pneumoniae infections in humans in conjunction with clinical and epidemiological risk factors.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070599 | MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER |
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