Bruker Gets FDA Clearance To Market MALDI BiotyperCA System In U.S.

(RTTNews) - Bruker Corp. (BRKR) announced it has been granted U.S. FDA clearance under Section 510(k) to market its MALDI BiotyperCA System in the United States for the identification of Gram negative bacterial colonies cultured from human specimens.

The MALDI BiotyperCA System includes the bench-top microflex MALDI-TOF mass spectrometer, software, IVD labeled reagents, a 48-spot MALDI target and a library of microorganism reference spectra.

Frank Laukien, President and CEO of Bruker said, "The MALDI Biotyper has been a success with more than 1,000 systems sold or leased worldwide. With clearance by the US FDA to market the MALDI Biotyper CA System, we expand our market reach into the largest clinical market in the world, with expected significant improvements in outcomes and reductions in the cost of healthcare."