VIROLOGY - NA REAGENTS - OTHER

Primary DI

06928103014011

Basic UDI-DI Code

B-06928103014011

Reference

DA1401

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Daan Gene Co., Ltd.

This kit is used for in vitro qualitative detection of novel coronavirus (2019-nCoV) nucleic acid in oropharyngeal swabs and anterior nasal swab specimens of suspected and clustered cases of novel coronavirus pneumonia (COVID-19), and other patients requiring diagnosis or differential diagnosis of 2019-nCoV infection. The results of this kit are for clinical reference only, instead of as the exclusive criterion for clinical diagnosis. It is recommended that the conditions of patients be comprehensively analyzed according to their clinical manifestations and other laboratory tests.

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