FDA has granted premarket notification (510(k)) clearance to the HemoFISH Masterpanel from Miacom Diagnostics, Düsseldorf, Germany. The test system detects bacteria directly from positive blood cultures. Using fluorescence in situ hybridization (FISH) technology and run in stat or batch mode, the test can identify both Gram-negative and Gram-positive bacteria in positive blood cultures in 30 minutes. Requiring minimum hardware, the test can simultaneously identify or differentiate such pathogens as Acinetobacter spp, coagulase-negative Staphylococci, E. coli, E. faecalis, E. faecium, Enterobacteriaceae, K. pneumoniae, P. aeruginosa, P. mirabilis, S. agalactiae, S. aureus, S. maltophilia. S. pneumoniae, Staphylococcus spp, and Streptococcus spp. For more information, visit Miacom Diagnostics.
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