VIROLOGY - NA REAGENTS - OTHER

Primary DI

08800204300652

Basic UDI-DI Code

B-08800204300652

Reference

RS001

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

KH Medical Co., Ltd.

The RADI STI-10 Detection KIT is an in vitro diagnostic medical device, based on Real-time RT-PCR technology to detect the common 10 sexually transmitted pathogen DNA. The kit is intended for the presumptive qualitative detection of nucleic acid extracted from the 10 sexually transmitted pathogens which are Mycoplasma genitalium, Ureaplasma parvum, Mycoplasma hominis, Ureaplasma urealyticum, Treponema pallidum, Trichomonas vaginalis, Candida albicans, Gardnerella vaginalis, Herpes Simples Virus 1and Herpes Simples Virus 2. The assay is for use by a laboratory professional trained to use real-time PCR in a laboratory.

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