VIROLOGY - NA REAGENTS - OTHER

Primary DI

06928103010716

Basic UDI-DI Code

B-06928103010716

Reference

DA1071

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 2019 novel coronavirus (2019-nCoV) ORF1ab and N gene in the oropharyngeal swab, nasal swab, saliva, and sputum specimens of suspected COVID-19 patients, clustering cases and others needing diagnosis or differential diagnosis for 2019-nCoV. This kit is only used for the auxiliary diagnosis of related cases during the pneumonia epidemic caused by 2019-nCoV infection and used for the emergency storage of in vitro diagnostic reagents against this epidemic, and it should not be used as regular in vitro diagnostic reagents for clinical diagnosis. When using this kit, the user should comply with the relevant requirements in respect to the detection, diagnosis and treatment for Pneumonia caused by 2019-nCoV, and carry out the 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 to conduct a comprehensive analysis on the condition in combination with the clinical manifestations of the patient and other laboratory tests.

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