INFLUENZA & PARA INFLUENZA - NA REAGENTS
Basic Information
- Primary DI
- 04049095210044
- Basic UDI-DI Code
- 4049095UN05050000PY
- Reference
- UN0505
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- R-Biopharm AG
Additional Description
For in vitro diagnostic use. The RIDA®UNITY Flu test, performed on the RIDA®UNITY platform, is a multiplex real-time PCR for the direct qualitative detection and differentiation of influenza virus (influenza A and influenza B) RNA in untreated human nasal/throat swabs from persons with signs and symptoms of acute respiratory infection. The RIDA®UNITY Flu test is intended to support the diagnosis of influenza virus infections in patients with symptoms of respiratory infection in connection with other clinical and laboratory findings. Negative results do not rule out infection with influenza virus and should not be used as the sole basis for diagnosis. The product is intended for professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040504 | INFLUENZA & PARA INFLUENZA - NA REAGENTS |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).