Vietnam MOH registration 2301809ĐKLH/BYT-HTTB

IVD Department Quantitative Analysis of Sirolimus

VN: Bộ IVD xét nghiệm định lượng Sirolimus

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Theo theo phụ lục·Registered Dec 30, 2023

Registration details

Analysis ID: 2301809ĐKLH/BYT-HTTB
Submission ID: 17002917/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Theo theo phụ lục
Manufacturer Country: Theo theo phụ lục

Technical details

Intended Use: 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

Registration Date: Dec 30, 2023

About this record

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.

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