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Qualitative DNA Test for Human papillomavirus (HPV) - 19 types of high-risk HPV and 9 types of low-risk HPV - Vietnam Registration 2400864ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Qualitative DNA Test for Human papillomavirus (HPV) - 19 types of high-risk HPV and 9 types of low-risk HPV in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2400864ĐKLH/BYT-HTTB and manufactured by Seegene, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG.

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2400864ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2400864ĐKLH/BYT-HTTB
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Device Details

Qualitative DNA Test for Human papillomavirus (HPV) - 19 types of high-risk HPV and 9 types of low-risk HPV
VN: Bộ xét nghiệm định tính ADN Human papillomavirus (HPV) - 19 tuýp HPV nguy cơ cao và 9 tuýp HPV nguy cơ thấp
Risk Class TTBYT Loại C

Registration Details

2400864ĐKLH/BYT-HTTB

17005529/ĐKLH-BYT-TB-CT

Allplex™ HPV28 Detection

HP10372X

Company Information

REPUBLIC OF

Technical Details

In vitro testing for the qualitative detection of human papillomavirus (HPV) includes 19 high-risk HPV types (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 73, 82) and 9 low-risk HPV types (6, 11, 40, 42, 43, 44, 54, 61, 70) from cervical and vaginal self-collected samples.

Dates and Status

Jun 24, 2024