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Medical testing services performed by a bench-top instrument, namely, the direct-from-specimen detection, identification, and characterization of invasive infections directly from biological blood specimens from individuals deemed as at risk for a bacterial or fungal invasive infection and for the purpose of patient care for that individual; excluding services related to genetic testing, genetic analysis, or population health management.

Medical in-vitro diagnostic equipment, namely a bench-top instrument for the direct-from-specimen detection, identification, and characterization of bacterial and fungal invasive infections directly from biological blood specimens from individuals deemed as at risk for bacterial or fungal invasive infection and for the purpose of patient care for that individual; disposable cassettes for use in medical in-vitro diagnostic equipment for the direct-from-specimen detection, identification, and characterization of bacterial and fungal invasive infections directly from biological blood specimens from individuals deemed as at risk for a bacterial or fungal invasive infection and for the purpose of patient care for that individual