Eu Ivdr
Eu Ivd Class B
On The Market
🇨🇳 China
EasyNAT Rapid RSV Assay
Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 06973492240206
- Basic UDI-DI Code
- 697349224U2020082B000G8
- Reference
- U20208
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Ustar Biotechnologies (Hangzhou) Ltd.
Additional Description
This assay is an automated, in vitro nucleic acid amplification test used for qualitative diagnosis of Respiratory Syncytial Virus nucleic acid in human throat swabs collected from individuals with signs and/or symptoms of respiratory viral infection. It is used in the auxiliary diagnosis of respiratory infection. The agent detected may not be the definite cause of disease and the Clinical diagnostic information is necessary to determine infection status. This assay is not for near patient and self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040505 | RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS |
Available In Countries
🇫🇷 France
🇳🇱 Netherlands
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