Device Dossier

General laboratory reagent and consumables IVDs

Device Dossier for General laboratory reagent and consumables IVDs (CT946 - General laboratory reagent and consumables IVDs, Class 2, sponsor Bruker).…

Intended purpose

The MBT Sepsityper IVD Kit is a sample preparation kit for the identification of microorganisms from positively flagged blood cultures using the MALDI-TOF mass spectrometer.

TGA Public Summary