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

IVD Bacterial Test Standard is a chemical composition containing an extract of the Escherichia coli DH5? bacteria (inactivated) and two additional proteins. It is used by the IVD MALDIO Biotyper to perform a quality control check of the microflex mass spectrometer settings. IVD matrix HCCA-portioned is a cinnamic acid derivative. It enables easy and convenient preparation of MALDI matrix for IVD MBT measurement and identification of test organism.

TGA Public Summary