Mycobacterium Tuberculosis Nucleic Acid and Rifampicin Resistance Detection Kit (Melting Curve)

Primary DI

D-0000128072020E2P6

Basic UDI-DI Code

B-0000128072020E2P6

Reference

HWTS-RT074

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

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

This kit is used for the in vitro qualitative detection of Mycobacterium tuberculosis DNA in human sputum, solid culture (L-J Medium) and liquid culture (MGIT Medium), bronchial lavage fluid, and the mutations in the 507-533 amino acid codon region (81bp, rifampicin resistance determining region) of the rpoB gene of Mycobacterium tuberculosis rifampicin resistance. It provides aid to the diagnosis of Mycobacterium tuberculosis infection, and it detects the main resistance genes of rifampicin, which helps to understand the drug resistance of Mycobacterium tuberculosis infected by the patient.

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