Vietnam MOH registration 230000348/PCBB-BYT

The DNA testing kit for the detection and differentiation of 14 types of high-risk human papilloma virus (HPV)

VN: Bộ xét nghiệm phát hiện và phân biệt DNA của 14 loại virus human papilloma (HPV) nguy cơ cao

Vietnam·Risk Class TTBYT Loại B·High Risk HPV ELITe Panel·OSANG Healthcare Co., Ltd.·Registered Oct 14, 2023

Registration details

Analysis ID: 230000348/PCBB-BYT
Submission ID: 000.00.04.G18-231014-0002
Product Type: High Risk HPV ELITe Panel

Company information

Manufacturer: OSANG Healthcare Co., Ltd.
Manufacturer Country: 14040

Technical details

Intended Use: The "High Risk HPV ELITe Panel" product is a multiplex nucleic acid amplification real-time test designed to qualitatively detect and differentiate the DNA of 14 types of high-risk human papillomavirus (HPV) that cause cervical cancer in samples of DNA extracted from cervical cytology samples. The test specifically identifies types HPV16 and HPV18 and simultaneously detects the remaining high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). This product is intended to be used as an in vitro diagnostic tool to support the diagnosis of HPV infection, in conjunction with the patient's clinical data and other laboratory test results.

Dates and status

Registration Date: Oct 14, 2023

About this record

Access comprehensive regulatory information for The DNA testing kit for the detection and differentiation of 14 types of high-risk human papilloma virus (HPV) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 230000348/PCBB-BYT and manufactured by OSANG Healthcare Co., Ltd..

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