2019-Novel Coronavirus (ORFlab, E & N genes) nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)

Primary DI

06970895476331

Basic UDI-DI Code

B-06970895476331

Reference

R205T050B0C2

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Jiangsu Mole Bioscience Co., LTD.

This kit is intended for the qualitative detection of ORF1ab, E & N genes of 2019-Novel Coronavirus (2019-nCoV, SARS-COV-2) in the specimens including nasopharyngeal swab, oropharyngeal swabs, bronchoalveolar lavage fluid, saliva, sputum, and fecal. The ORF1ab gene sequences are higher specificity for 2019-nCoV, while the sequences of the E and N genes are homogenous to the same genes in some viruses such as SARS-like coronaviruses and coronaviruses carried by some bats.

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