Bruker Daltonics MBT Compass IVD MALDI Biotyper System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

BRUKER SINGAPORE PTE. LTD.

Class:

Class C IVD

Manufactured by:

Bruker Daltonics GmbH & Co.KG

Therapeutic area:

Microbiology

Therapeutic indications:

The intended use of the Bruker IVD MALDI Biotyper application (referred to as "IVD MALDI Biotyper") is the calculation of the similarity of a mass spectrometry-based pattern profile of an unknown microorganism to mass spectrometry- based pattern profiles of characterized strains stored in a reference library. This allows identification of unknown microorganisms (bacteria and yeasts) at the species level after standardized sample preparation procedures.

Product summary:

Device System Info:[System or Procedure Pack]; Models: Microflex LT/SH - 8605089, Microflex LT/SH smart - 8605200, IVD Bacterial Test standard - 8290190, IVD Matrix HCCA portioned - 8290200, MBT Compass IVD - 1832771, MBT Satellite IVD Module - 1834056, MALDI Biotyper sirius IVD System - 1890112, MALDI Biotyper sirius one IVD System - 1890212, MBT Mycobacteria IVD Module - 1850731

Authorization date:

2018-02-06