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Bruker MALDI Biotyper™ Gets Clearance as a Medical Device from CFDA

Bruker has received clearance from the China Food and Drug Administration (CFDA) to market and sell its IVD MALDI Biotyper System as a medical device in China for the identification of microorganisms isolated from human specimens.

MALDI Biotyper-based microbial identification has major advantages compared to classical automated biochemical testing, including faster time to result (TTR) and better information with deeper and broader species coverage. Starting from a culture, the IVD MALDI Biotyper allows for microbial identification in a few minutes without further time-consuming incubation steps.  With this paradigm shift in clinical practice, microbial identification is typically available one day earlier than with biochemical techniques. Additionally, MALDI-TOF mass spectrometry-based identification does not have the limitations of biochemical testing and can analyze species that have been difficult to identify by previous microbiology techniques. An increasing number of case reports describe the identification of microorganisms causing human infections which previously have been isolated only from environmental sources. The comprehensive IVD MALDI Biotyper reference library now covers more than 2,300 microbial species of gram-negative bacteria, gram-positive bacteria, anaerobes and yeasts, and often enables the identifications of unexpected microorganisms.

The IVD MALDI Biotyper System includes the bench-top microflex™ MALDI-TOF (matrix-assisted laser desorption ionization time-of-flight) mass spectrometer, automated analysis software, the IVD Bacterial Test Standard (BTS), a 96-spot MALDI target and an extensive library of microorganism reference entries. The microflex is the market-leading MALDI-TOF mass spectrometer for microbiology with a number of unique features specifically designed for applications in routine laboratories:

  • State-of-the-art benchtop system to save lab space
  • Fiber optics laser coupling for optimized robustness after preventive maintenance or service
  • Self-cleaning ion source for optimized robustness in high-throughput applications
  • Oil-free membrane pump for quiet operation in routine laboratories
  • Rapid exchange of target plates to reduce delays between measurement runs
  • Smart Spectra Acquisition™ saves laser life-time and increases speed of analysis

     
Tags: Identification, MALDI-TOF, Antibiotic Resistance

Date Published: June 27, 2014

Source article link: Bruker Daltonics » company contact details
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