EasyNAT Rapid Flu Assay

Primary DI

06973492240190

Basic UDI-DI Code

697349224U2020062B000FE

Reference

U20206

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Ustar Biotechnologies (Hangzhou) Ltd.

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.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).