INFLUENZA & PARA INFLUENZA - NA REAGENTS

Primary DI

06928103002902

Basic UDI-DI Code

B-06928103002902

Reference

DA0290

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 human influenza virus subtype H1 (IV H1) ribonucleic acid in oropharyngeal swab samples. Laboratory personnel shall be professionally trained in gene amplification and molecular biology detection, and be qualified for relevant experimental operation, and the laboratory should have reasonable biosafety protection facilities and safeguard procedures. The test results of this kit are for clinical reference only, and shall 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).