Vietnam MOH registration 2400864ĐKLH/BYT-HTTB

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
Vietnam flagVietnam·Risk Class TTBYT Loại C·Allplex™ HPV28 Detection·Seegene, Inc.·Registered Jun 24, 2024
Registration details
Analysis ID
2400864ĐKLH/BYT-HTTB
Submission ID
17005529/ĐKLH-BYT-TB-CT
Product Type
Allplex™ HPV28 Detection
Product Code
HP10372X
Company information
Manufacturer
Seegene, Inc.
Manufacturer Country
REPUBLIC OF
Technical details
Intended Use
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
Registration Date
Jun 24, 2024
About this record

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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