Vietnam MOH registration 240002754/PCBB-HN

Norovirus Qualitative Antigen Test Kit

VN: Khay thử xét nghiệm định tính kháng nguyên Norovirus

Vietnam·Risk Class TBYT Loại B·Norovirus Antigen Test·Hangzhou Testsea Biotechnology Co., Ltd.·Registered Oct 14, 2024

Registration details

Analysis ID: 240002754/PCBB-HN
Submission ID: 000.00.19.H26-240927-0027
Product Type: Norovirus Antigen Test
Product Code: 101026

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: Norovirus Antigen Testing is a rapid immunochromatographic test for the qualitative detection of Norovirus in human fecal samples, to aid in the diagnosis of Norovirus infection.

Dates and status

Registration Date: Oct 14, 2024

About this record

Access comprehensive regulatory information for Norovirus Qualitative Antigen Test Kit 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 240002754/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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