Vietnam MOH registration 240002744/PCBB-HN

Ag H.Pylori Qualitative Test

VN: Khay thử xét nghiệm định tính Ag H.Pylori

Vietnam·Risk Class TBYT Loại B·H.Pylori Ag Test·Hangzhou Testsea Biotechnology Co., Ltd.·Registered Oct 14, 2024

Registration details

Analysis ID: 240002744/PCBB-HN
Submission ID: 000.00.19.H26-240927-0015
Product Type: H.Pylori Ag Test
Product Code: 101014

Company information

Manufacturer: Hangzhou Testsea Biotechnology Co., Ltd.
Product Owner: Hangzhou Testsea Biotechnology Co., Ltd.
Authorized Representative: CÔNG TY TNHH THIẾT BỊ Y TẾ VÀ THIẾT BỊ VĂN PHÒNG HỒNG HẠNH

Technical details

Intended Use: H. Pylori Ag Testing is an immunoassay chromatographic rapid test for the qualitative detection of H. pylori (HP) antigen in whole blood/serum/plasma.

Dates and status

Registration Date: Oct 14, 2024

About this record

Access comprehensive regulatory information for Ag H.Pylori Qualitative Test in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002744/PCBB-HN and manufactured by Hangzhou Testsea Biotechnology Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ VÀ THIẾT BỊ VĂN PHÒNG HỒNG HẠNH.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.