IVD Department Quantitative Analysis of Sirolimus - Vietnam Registration 2301809ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department Quantitative Analysis of Sirolimus 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 2301809ĐKLH/BYT-HTTB and manufactured by Theo theo phụ lục.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
2301809ĐKLH/BYT-HTTB
17002917/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
Elecsys Sirolimus: An in vitro immunoassay test used to quantify sirolimus in whole blood. The test is used to support the monitoring of kidney transplant patients treated with sirolimus. The ECLIA (Electrochemiluminescence Immunoassay) test is used on the Elecsys and cobase immunoassay analyzers. Sirolimus CalSet: The Sirolimus CalSet is used to calibrate the quantitative Elecsys Sirolimus immunoassay test on the cobase immunoassay analyzer.
Dates and Status
Dec 30, 2023