32d84ad7-b90b-4875-8954-41db66379e8bNewPublished12023-04-062023-03-29In Commercial DistributionB6011002000PrimaryHIBCCFAST PBC Prep Cartridge110-02-00251371170Qvella Corporation1The FAST™ System and FAST PBC Prep Cartridge are intended for the automated isolation and concentration of a suspension of bacterial cells from positive blood culture (PBC) bottles for in vitro diagnostic use. The FAST™ System and FAST PBC Prep Cartridge have not been validated for any downstream diagnostic procedures or applications and are only indicated for positive blood culture specimens containing bacteria. The FAST PBC Prep Cartridge is only for use with the FAST™ System. The FAST™ System and FAST PBC Prep Cartridge are intended for use by trained and qualified laboratory personnel.falsetruefalsefalsefalsetruetruetruetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse833-478-3552TechSupport@qvella.com17452Microsample centrifuge IVDAn electrically-powered device intended to be used mainly in the clinical laboratory to centrifuge small sample volumes (typically from 0.25 to 2.2 ml) through centrifugal force. It is typically a compact stationary structure with an electric motor, a rotor, a shaft, and speed and time controls. It may include a vortex mixing function and/or refrigerating capabilities to keep cool the rotor chamber or to perform temperature sensitive procedures. The device is intended to spin down microorganisms, cells, precipitates, or reagent solutions prior to subsequent in vitro diagnostic procedures; it may also sediment viruses and cellular organelles.falseActiveJJHClinical Sample ConcentratorStorage Environment Temperaturefalsefalse