Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus

Primary DI

06974849366211

Basic UDI-DI Code

B-06974849366211

Reference

HWTS-UR010A

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

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

This kit is intended for the in vitro qualitative detection of the nucleic acid DNA of group B streptococcus in rectal swab samples, vaginal swab samples or mixed rectal/vaginal swab samples from pregnant women at 35 to 37 gestational weeks with high risk factors and at other gestational weeks with clinical symptoms such as premature rupture of membrane and threatened premature labor.

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