VIROLOGY - NA REAGENTS - OTHER

Primary DI

06928103011614

Basic UDI-DI Code

B-06928103011614

Reference

DA1161

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 S gene mutations L452R, T478K, and P681R in 2019-nCoV Delta Variant in the oropharyngeal swabs, nasopharyngeal swabs, and saliva specimens from suspected pneumonia cases infected by novel coronavirus, clustered cases and others needing diagnosis or differential diagnosis for novel coronavirus to identify 2019-nCoV Delta variant. The product is used for supplementary diagnosis of related cases and as an emergency reserve for in vitro diagnosis only during the outbreak of COVID-19 caused by 2019-nCoV. It cannot be used as a conventional in vitro diagnostic reagent for clinical purpose. Detection of novel coronavirus RNA shall meet with relevant requirements of regulations on biosafety. The detection results of this kit are for clinical reference only and should not be used as the sole criteria for clinical diagnosis. It is recommended that a comprehensive analysis for patient’s condition be conducted in combination with the clinical manifestations of patient and other laboratory tests.

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