Treponema pallidum antibody qualitative test reference standard drug - Vietnam Registration 2403558ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2403558ĐKLH/BYT-HTTB
18008064/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
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
Nov 14, 2024