Vietnam MOH registration 2400627ĐKLH/BYT-HTTB

Quantitative/Qualitative Antibody Test for Chlamydia trachomatis

VN: Bộ xét nghiệm định lượng/định tính kháng thể IgG kháng Chlamydia trachomatis

Vietnam·Risk Class TTBYT Loại C·SERION ELISA classic Chlamydia trachomatis IgG·Institut Virion\Serion GmbH·Registered May 10, 2024

Registration details

Analysis ID: 2400627ĐKLH/BYT-HTTB
Submission ID: 17003475/ĐKLH-BYT-TB-CT
Product Type: SERION ELISA classic Chlamydia trachomatis IgG
Product Code: ESR1372G

Company information

Manufacturer: Institut Virion\Serion GmbH
Manufacturer Country: GERMANY
Product Owner: Institut Virion\Serion GmbH
Authorized Representative: CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA

Technical details

Intended Use: The SERION ELISA classic Chlamydia trachomatis IgG tests are qualitative and quantitative immunoassays designed to detect IgG antibodies in serum or plasma against Chlamydia trachomatis and are recommended for the diagnosis of acute, newly acquired, and chronic infections.

Dates and status

Registration Date: May 10, 2024

About this record

Access comprehensive regulatory information for Quantitative/Qualitative Antibody Test for Chlamydia trachomatis 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 2400627ĐKLH/BYT-HTTB and manufactured by Institut Virion\Serion GmbH. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA.

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