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 diagnostic equipment, namely, portable direct-from-specimen testing instruments for in vitro diagnostics of invasive infections