RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS

Primary DI

06976055490094

Basic UDI-DI Code

B-06976055490094

Reference

NA

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD

This product is designed for the in vitro qualitative detection of RNA from Influenza A virus (Flu A), Influenza B virus (Flu B), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and respiratory syncytial virus (RSV) in throat swabs. It is an in vitro diagnostic reagent that utilizes real-time fluorescence PCR, run on Auto Quantitative PCR System Deaou-ART04. The detection results are intended for clinical auxiliary diagnosis only and should not be used as the sole basis for diagnosing or excluding cases.

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