Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

Human Papillomavirus (HPV) Typing Detection Kit ( Reversible Terminator Sequencing)

GeneMind Biosciences Co., Ltd. · 🇨🇳 China
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06974968583216
Basic UDI-DI Code
B-06974968583216
Reference
L000047
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

Belonging to the Papillomaviridae family, human papillomavirus (HPV) is a kind of cyclic dsDNA virus in small molecule without coating by tunica. With a rough length of 8000 bp, the genome is divided into 3 functional spacers, namely early stage transcribed spacer (E spacer), late stage transcribed spacer (L spacer), and non-transcribed spacer (long control region, LCR). Human can be infected by HPV directly or indirectly through contacting contaminants or sexually transmitted infection. Featured with not only the host specificity, but also the tissue specificity, this virus can only infect epithelial cells of human skin and mucosa, resulting in skin varied of papilloma or verruca, and genital tract epithelial hyperplasia injury. HPV commonly infects the genital tract of females who have a sex life. According to the statistics, 70%-80% of females have at least one infection in their lives. However, most of them belong to a self-limiting infection. More than 90% of infected females developed an effective immune response, whose infection can be cleared within 6-24 months in the absence of any long-term health intervention. However, continuous high risk HPV infection is the major cause resulting in cervical intraepithelial neoplasia and cervix carcinoma. Results of global researches show that high risk HPV DNA has been detected in the body of 99.7% of cervix carcinoma patients. Generally, low risk HPV is related to condyloma acuminatum lesion or low grade squamous intraepithelial lesions, rarely resulting in infiltrating carcinoma. Due to lacking effective treatments generally accepted to HPV, and considering that the carcinoma lesion can develop into two directions (development and reversion) at any period before developing to infiltrating carcinoma, early detection and prevention from high risk HPV are the key to blocking carcinoma lesion

CND Nomenclature Codes

Code Description
W01030499 TISSUE TYPING REAGENTS - OTHER

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