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

Primary DI

D-0000128072000E0NL

Basic UDI-DI Code

B-0000128072000E0NL

Reference

HWTS-RT147

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, as well as the mutations in the main mutation sites of Mycobacterium tuberculosis isoniazid resistance. It provides aid to the diagnosis of Mycobacterium tuberculosis infection, and it detects the main resistance genes of rifampicin and isoniazid, 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).