INFLUENZA & PARA INFLUENZA - NA REAGENTS
Basic Information
- Primary DI
- 06973492240190
- Basic UDI-DI Code
- B-06973492240190
- Reference
- U20206
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Ustar Biotechnologies (Hangzhou) Ltd.
Additional Description
This assay is an automated, in vitro nucleic acid amplification test used for the rapid qualitative detection and discrimination of the RNA from influenza A and B viruses in human throat swabs from individuals with signs and/or symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. It is intended for non-pandemic influenza detection only. The test results should not be used as the sole basis for treatment or management decisions. Clinical observations, patient history, and/or epidemiological information must be taken into account. This assay is not for near patient and self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040504 | INFLUENZA & PARA INFLUENZA - NA REAGENTS |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).