Eu Ivdd Eu Ivd General No Longer On The Market 🇫🇮 Finland

Cascadion™ SM Immunosuppressants Panel Internal Standard

Thermo Fisher Scientific Oy · 🇫🇮 Finland
Devices (same UDI-DI)
1
Certificates
0
Countries
17
Notified Bodies
0

Basic Information

Primary DI
D-100187776A
Basic UDI-DI Code
B-100187776A
Reference
10018777
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
No Longer On The Market

Additional Description

Intended use: The Cascadion™ SM Immunosuppressants Panel is for the quantitative determination of cyclosporin A, tacrolimus, sirolimus, and everolimus in human whole blood by a single injection on the Cascadion™ SM Clinical Analyzer. This liquid-chromatography - tandem mass spectrometry (LC-MS/MS) assay is to be used as an aid in the management of transplant patients receiving therapies with these drugs. This in vitro diagnostic device is intended for clinical laboratory use only. The Cascadion™ SM Immunosuppressants Panel Internal Standard is used to ensure the accuracy of the assay on the Cascadion™ SM Clinical Analyzer by correcting for systematic and random errors due to variations in sample preparation, chromatography, and detection. The Internal Standard is also used as a precipitating agent in the sample preparation method.

CND Nomenclature Codes

Code Description
W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇩🇪 Germany 🇩🇰 Denmark 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇮🇪 Ireland 🇮🇹 Italy 🇱🇺 Luxembourg 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇸🇪 Sweden 🇬🇧 United Kingdom

Similar Devices

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).

View all