GENEDIAN

Primary DI

D-RA005UK

Basic UDI-DI Code

B-RA005UK

Reference

P122-08048; P122-08240; P122-08480

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Hangzhou DIAN Biotechnology Co., Ltd.

The kit is suitable for DNA typing test of human papillomavirus (6, 11, 16, 18, 31, 33, 35, 39, 42, 45, 51, 52, 53, 56, 58, 59, 66, 68, 70, 73, 81 ,82, 83). The human papillomavirus is a double-stranded closed-loop small DNA virus that contains approximately 8,000 base pairs. The shape of the virus is spherical, with a diameter of 52nm～55nm,octahedron is three-dimensionally symmetrical and the outer surface of the virus has no envelope. The virus is epithelial, the only host is human and has a high host-specific affinity. The kit designs specific primer probes for 23 types of L1 genes on the L1 gene of HPV and uses PCR amplification combined with molecular beacon melting curve technology to detect the type of HPV. The kit first amplifies 23 types of HPV-specific fragments and the amplified product hybridizes with the designed molecular beacon probe. The instrument collects the fluorescence signal and judges the type of HPV by the corresponding Tm value The kit is used for auxiliary diagnosis of human papillomavirus infection to identify the specific types of human papillomavirus in each group. The results of the kit are for clinical reference only and should not be used as the sole basis for diagnosis or exclusion.

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