VIROLOGY - NA REAGENTS - OTHER

Primary DI

06928103010600

Basic UDI-DI Code

B-06928103010600

Reference

DA1060

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 the in vitro qualitative detection of SARS-CoV-2 N gene, SARS-CoV-2 UK Variant (B.1.1.7 ) and South African Variant (B.1.351) common mutant S gene (N501Y) , SARS-CoV-2 UK Variant (B.1.1.7 ) mutant S gene (HV 69-70del), SARS-CoV-2 South African Variant (B.1.351) mutant S gene (K417N) in the nasopharyngeal swabs, oropharyngeal swabs, saliva specimens of suspected pneumonia cases infected by novel coronavirus, suspected clustering cases and others needing diagnosis or differential diagnosis for novel coronavirus to identify B.1.1.7 and B.1.351 virus strains.

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