ViroKey MP HPV 16, 18 PCR Test

Primary DI

D-888501395VKMPHPV1618TZ6

Basic UDI-DI Code

B-888501395VKMPHPV1618TZ6

Reference

301119, 301120, 301121

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The ViroKey MP HPV 16, 18 PCR Test is a real-time PCR based in vitro diagnostic test to be used for qualitative detection of 18 genotypes of human papillomavirus (HPV) DNA, including the differentiation of high-risk HPV genotypes 16 and 18 from types 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 and 82 in cervical shedding cell samples, aiding in the diagnosis of HPV infection. The test results of this kit are for clinical reference only and shall not be used as the sole basis for diagnosis or exclusion, and should be analyzed by combining with clinical symptoms/signs, medical history, treatment responses and results of other laboratory examinations. The ViroKey MP HPV 16, 18 PCR Test are intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and its procedures.

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