VIROLOGY - NA REAGENTS - OTHER

Primary DI

06928103011706

Basic UDI-DI Code

B-06928103011706

Reference

DA1170

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Daan Gene Co., Ltd.

This kit is intended for in vitro qualitative test for novel coronavirus nucleic acid in specimens including oropharyngeal swabs, nasopharyngeal swab, and sputum in novel coronavirus-related suspected cases, clustered cases, and other cases requiring novel coronavirus infection diagnosis and differential diagnosis. Detection of novel coronavirus RNA shall meet with relevant requirements of regulations on biosafety. Test result of this kit is for clinical reference only, instead of being the sole criteria for clinical diagnosis. It is recommended that patients’ clinical features and other laboratory tests be taken into account for comprehensive analysis of diseases. This kit, used as emergency storage only, is for supplementary diagnosis of related cases and as in vitro diagnostic reagent during the pandemic of novel coronavirus and its infection-related pneumonia.

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