SCREENING HIGH-RISK HPV - NA REAGENTS

Primary DI

06950917910579

Basic UDI-DI Code

B-06950917910579

Reference

C011938

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Triplex International Biosciences (China) Co., LTD.

The kit is suitable for the in vitro qualitative detection of HPV subtypes 16 and 18 nucleic acid in female cervical samples. This kit has not been clinically tested and cannot be used for cervical screening. A positive result can only indicate single or mixed HPV16 and 18 infection in clinical samples and cannot distinguish the two. The results are for clinical reference only and should not be used as the sole basis for disease diagnosis or exclusion.

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