FDAnews Device Daily Bulletin

Bruker Gets FDA Clearance for Expanded MALDI Biotyper Claim

Aug. 3, 2017

The FDA has cleared Bruker for a further expanded claim for the company’s microbial identification system.

The expansion covers 144 new species of microbe, bringing the Biotyper’s library to 424 microbial species cleared for the microbiology market. It also includes a series of new disposable biotargets derived from the company’s AnchorChip technology.

The expanded claim covers expanded workflow tools, including an optically-guided target preparation assistance tool.

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