Vietnam MOH registration 2403558ĐKLH/BYT-HTTB

Treponema pallidum antibody qualitative test reference standard drug

VN: Thuốc thử, chất hiệu chuẩn xét nghiệm định tính kháng thể kháng Treponema pallidum

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Registered Nov 14, 2024

Registration details

Analysis ID: 2403558ĐKLH/BYT-HTTB
Submission ID: 18008064/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: In vitro immunoassay for the qualitative determination of antibodies against Treponema pallidum in human serum and plasma. This test is used as a supportive diagnostic tool for syphilis. The ECLIA fluorescent immunoassay is used on the Elecsys and cobas e platforms.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for Treponema pallidum antibody qualitative test reference standard drug in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2403558ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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