OTHER HPV - NA REAGENTS

Primary DI

06928103011805

Basic UDI-DI Code

B-06928103011805

Reference

DA1180

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Daan Gene Co., Ltd.

This detection kit is intended for in vitro qualitative detection of 14 genotypes of human papilloma viruses (HPV) DNA in female cervical exfoliated cells, including type 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, among which type 16 and 18 can be specifically identified using this kit while the remaining 12 types are not specifically identified. This kit is mainly used for: ①For patients whose cytological examination is atypical squamous cells of undetermined significance (ASC-US), it is used to determine the necessity of colposcopy. This result is not a substitute for colposcopy. ②For women aged 30 and over, cervical cancer screening is performed by high-risk HPV test in combination with cervical cytology. The test results, combined with the cytology history, and evaluation of other risk factors and professional guidelines, can be used to guide the treatment of patients. ③For women aged 30 and over, cervical cancer screening is performed by high-risk HPV test. The test results, combined with the cytology history, and evaluation of other risk factors and professional guidelines, can be used to guide the treatment of patients. This result is not a substitute for colposcopy.

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