Rapid identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR)

Primary DI

06974849366167

Basic UDI-DI Code

B-06974849366167

Reference

HWTS-RT078A

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

This kit is intended to conduct, in vitro qualitatively, the rapid differential diagnosis of main mutation sites P681H and HV69-70del of B.1.1.7 mutant strain, main mutation sites E484K and K417N of B.1.351 and P.1 mutant strains, and their common mutation site N501Y for the cases and clustered cases suspected with SARS-CoV-2-infected pneumonia and other cases required for the diagnosis of SARS-CoV-2 infection, positive for SARS-CoV-2 ORF1ab gene in the sputum and throat swab samples.

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