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

Primary DI

D-0000128071390DAS4

Basic UDI-DI Code

B-0000128071390DAS4

Reference

HWTS-RT105

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

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

The kit is used for the in vitro qualitative detection of the mutations in mycobacterium tuberculosis complex nucleic acid and sputum samples positive for mycobacterium tuberculosis complex from tuberculosis patients, which are in the 507-533 amino acid codon region (81bp, rifampicin resistance-determining region) of rifampicin-resistant rpoB gene, and in the main mutation sites of isoniazid resistance, such as InhA promoter region -15C>T, -8T>A, -8T>C; AhpC promoter region -12C>T, -6G>A; KatG 315 codon 315G>A, 315G>C; InhA 94 codon T>G. This product cannot determine the specific mutation type.

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