Vietnam MOH registration 240002756/PCBB-HN

Khay thử xét nghiệm định tính kháng thể bệnh lao TB

Vietnam·Risk Class TBYT Loại B·TB Tuberculosis Antibody Test·Hangzhou Testsea Biotechnology Co., Ltd.·Registered Oct 14, 2024

Registration details

Analysis ID: 240002756/PCBB-HN
Submission ID: 000.00.19.H26-240927-0030
Product Type: TB Tuberculosis Antibody Test
Product Code: 101018

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: The Tuberculosis Antibody Test is a rapid immunoassay test to detect the presence of antibodies against tuberculosis (TB) in the whole blood/plasma/serum to aid in the diagnosis of tuberculosis.

Dates and status

Registration Date: Oct 14, 2024

About this record

Access comprehensive regulatory information for Khay thử xét nghiệm định tính kháng thể bệnh lao TB 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 240002756/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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