PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS

Primary DI

06937044500859

Basic UDI-DI Code

B-06937044500859

Reference

1060015

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Ningbo HEALTH Gene Technologies Co., LTD.

The SureX® HPV 25X Genotyping Kit is a diagnostic test of human papillomavirus (HPV) in cervical specimens. The test utilizes amplification of target DNA by multiplex Polymerase Chain Reaction (PCR) and capillary electrophoresis to detect and genotype 25 HPV types in a single analysis. The HPV types identified by the kit are 6, 11, 16, 18,26, 31, 33, 35, 39, 42, 43, 44, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 81, 82 and 83. The test result can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk or low risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

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