Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
RSV Rapid Test Device
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06971792053069
- Basic UDI-DI Code
- B-06971792053069
- Reference
- K311416D
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou Realy Tech Co.,Ltd.
Additional Description
The RSV Rapid Test Device is an in vitro diagnostic test for the qualitative detection of Respiratory Syncytial Virus antigens in Nasal Swab, nasopharyngeal swab and nasal aspirate samples, using the rapid immunochromatographic method.The identification is based on the monoclonal antibodies specific for the F protein of the Respiratory Syncytial Virus. It will provide information for clinical doctors to prescribe correct medications. Negative results should be confirmed by other methods, such as cell culture.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040605 | RESPIRATORY SYNCYTIAL VIRUS (RSV) |
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