Vietnam MOH registration 2400628ĐKLH/BYT-HTTB

Quantitative/Qualitative Test Kit for IgG Antibodies Against Chlamydia pneumoniae

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

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

Registration details

Analysis ID: 2400628ĐKLH/BYT-HTTB
Submission ID: 17003473/ĐKLH-BYT-TB-CT
Product Type: SERION ELISA classic Chlamydia pneumoniae IgG
Product Code: ESR1371G

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 pneumoniae IgG test is a quantitative and qualitative immunological test designed to detect IgG antibodies against Chlamydia pneumoniae in serum or plasma and is recommended for diagnosing recent, acute, and chronic infections.

Dates and status

Registration Date: May 10, 2024

About this record

Access comprehensive regulatory information for Quantitative/Qualitative Test Kit for IgG Antibodies Against Chlamydia pneumoniae 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 2400628ĐKLH/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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