HPV REAGENTS - OTHER

Primary DI

08800204300669

Basic UDI-DI Code

B-08800204300669

Reference

RS002

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

KH Medical Co., Ltd.

The RADI HUMAN PAPILLOMAVIRUS Detection KIT is an in vitro diagnostic medical device, based on Real-time RT-PCR technology to screen the HUMAN PAPILLOMAVIRUS DNA. The kit is intended for the presumptive qualitative screening of nucleic acid extracted from the 2 High risk HUMAN PAPILLOMAVIRUS 16 (HEX) and HUMAN PAPILLOMAVIRUS18 (ROX) and the other comparative low risk genotypes (HUMAN PAPILLOMAVIRUS 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68-FAM) in human urine and vaginal swab specimen. 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).