MYCOBACTERIAL DETECTION BY NA REAGENTS

Primary DI

06976055490155

Basic UDI-DI Code

B-06976055490155

Reference

NA

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD

This product is used for in vitro qualitative detection of DNA of Mycobacterium tuberculosis in sputum sample. This product is based on the real-time fluorescent PCR probe - melting curve technology and performed on Auto Quantitative PCR System, which is used to distinguish mycobacterium tuberculosis complex from nontuberculosis mycobacteria in clinical patients suspected of tuberculosis and nontuberculosis mycobacteria disease, and further used to detect the rifampin-resistance associated mutations in the 507-533bp region (rifampin-resistance determining region, RRDR) of rpoB gene in Mycobacterium tuberculosis complex, for clinical auxiliary diagnosis.

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