INFLUENZA & PARA INFLUENZA - NA REAGENTS

Primary DI

06928103002308

Basic UDI-DI Code

B-06928103002308

Reference

DA0230

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Daan Gene Co., Ltd.

The product is intended for qualitative detection of influenza A virus (IVA) RNA in human oropharyngeal swab specimens. Laboratory personnel should be professionally trained on gene amplification and molecular biology detection, and be qualified for relevant test operation, and the laboratory should have reasonable bio-safety protection facilities and protective procedures. The test results of this kit are for clinical reference only, and should not be used as the sole basis for clinical diagnosis.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).