Vietnam MOH registration 240002743/PCBB-HN

Que/ Khay thử xét nghiệm định tính Ab H.Pylori

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

Registration details

Analysis ID: 240002743/PCBB-HN
Submission ID: 000.00.19.H26-240927-0013
Product Type: H.Pylori Ab Test
Product Code: 101013

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 Ab Testing is an immuno-precipitation rapid test to detect the presence of antibodies against H. pylori (HP) in the whole blood/serum/plasma.

Dates and status

Registration Date: Oct 14, 2024

About this record

Access comprehensive regulatory information for Que/ Khay thử xét nghiệm định tính Ab H.Pylori 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 240002743/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.

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