Nucleic Acid Detection and HPV16/18 Genotyping Kit for 14 types of High-Risk Human Papillomavirus (Fluorescent PCR)

Primary DI

06970877681319

Basic UDI-DI Code

B-06970877681319

Reference

1201

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Kangmei Tianhong Biotech (Beijing) Co., Ltd.

The kit is suitable for qualitative detection of 14 kinds of high-risk human papillomavirus (including HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 66) nucleic acid material DNA in female cervical exfoliated cell samples in vitro, and to detect HPV16 and HPV18 types among them. This product has not been used in cervical cancer screening because of the special clinical research on the above 14 types of HPV infection and cervical cancer.

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