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

Primary DI

06970895476355

Basic UDI-DI Code

B-06970895476355

Reference

R205T010B0C2

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 qualitative detection of ORF1ab, E & N genes of 2019-Novel Coronavirus (2019-nCoV, SARS-COV-2) in the specimens including nasopharyngeal swab, Oropharyngeal swab, bronchoalveolar lavage fluid and sputum. 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 virus such as SARS-like coronaviruses and coronaviruses carried by some bats. For professional in-vitro diagnostic use.

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