Device typeMultiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT): A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorgansims associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT).
FDA categoryGram-positive bacteria and their resistance markers, SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN
Device ID00840487101575
Catalog number20-006-018
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information