REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Primary DI

06975146600039

Basic UDI-DI Code

B-06975146600039

Reference

100 tests/kit

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

BioDetect（Xiamen）Biotechnology Co., Ltd.

The kit is a TaqMan probe real-time fluorescent PCR to qualitatively detect ORF1ab and N genes nucleic acid of 2019-nCoV in nasopharyngeal in patients with respiratory infection symptoms and close contacts. The test results are for clinical reference only and cannot be used as a basis for confirming or eliminating cases. Operators should have experience of professional training in gene amplification or molecular biology method testing, and have relevant qualifications for laboratory operations. The laboratory should have reasonable biological safety precautions and protective procedures.

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