Group B Streptococcus Nucleic Acid Detection Kit (Fluorescent Probe-based Real-time PCR Assay)

Primary DI

06970895477017

Basic UDI-DI Code

B-06970895477017

Reference

B081T025B0C0

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Jiangsu Mole Bioscience Co., LTD.

This kit is used for the qualitative detection of Group B Streptococcus (GBS) DNA nucleic acid in vaginal secretions or rectal secretions of pregnant women at 34-38 weeks of pregnancy. Group B Streptococcus, also known as Streptococcus agalactiae, is one of the important pathogenic bacteria of reproductive tract infections in pregnant women. It can lead to urinary system infections, puerperal infections, and maternal sepsis, etc., and are related to some diseases such as premature delivery, premature rupture of membranes, early and late neonatal infections (such as septicemia, meningitis).

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