GENEDIAN

Primary DI

D-RA011UE

Basic UDI-DI Code

B-RA011UE

Reference

P122-02096

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Hangzhou DIAN Biotechnology Co., Ltd.

This test kit is used for in-vitro qualitative detection of nucleic acid DNA of 13 high risk human papilloma viruses (16, 18, 31, 33, 45, 52, 58, 35, 39, 51, 56, 59, 68) and 3 medium risk human papilloma viruses (53, 66, 82). This test kit is suitable for ASC-US population differentiation and is suitable for the patients whose cervical cells cytological results are ASC-US (atypia squamous epithelial cells with undetermined significance) to determine whether the colposcopy needs to be done. Test results need to be comprehensively analyzed by considering cervical cells cytological results and other relevant medical examination results and cannot be used as the basis for management of the patients. The application of the HPV nucleic acid test reagent should meet the requirements of relevant clinical diagnosis and treatment and screening guidelines. Human papilloma viruses are main pathogens which induce verruca acuminata and cervical lesions in women. Depending on the genotype, their pathogenicity or carcinogenesis risk can be classified as the low-risk type and high-risk type. The high-risk persistent infection is correlated with the high-level cervical intraepithelial neoplasias and invasive cervical cancer. The high-risk HPV test is used for differentiation and cervical cancer screening of the patients with abnormal cervical cells cytological results. Such test can effectively increase the positive rate of cervical lesions, improve the cytologic examination sensitivity and decrease the screening frequency.

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