Risby Drug Monitoring Kit - Immunosuppressive drugs - Taiwan Registration 85b7020b0c1c03bf838ec0aa0d95f536
Access comprehensive regulatory information for Risby Drug Monitoring Kit - Immunosuppressive drugs in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 85b7020b0c1c03bf838ec0aa0d95f536 and manufactured by RECIPE CHEMICALS + INSTRUMENTS GMBH. The authorized representative in Taiwan is AMEDx International Co., Ltd..
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Device Details
Product Details
This system is a universal drug monitoring platform that can be used for liquid chromatography coupled tandem mass spectrometry (LC-MS/MS) to monitor therapeutic drug monitoring TDM, and the Risby Immunosuppressive Drug Add-on Kit can quantitatively detect and monitor the concentrations of Cyclosporin A, tacrolimus, sirolimus and everolimus in human whole blood in a clinically relevant range.
A Clinical chemistry and clinical toxicology
A.1660 Quality control materials (analytical and non-analytical); A.1678 Tacrolimus drug monitoring system;; A.1235 Cyclosporine test system
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Aug 05, 2022
Aug 05, 2027