Device typeMultiple-type bloodstream pathogen nucleic acid IVD, reagent: A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorganisms associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate.
FDA categoryDirect Blood Bacterial Nucleic Acid Detection System
Device IDM70880073423
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information