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BioFire® Joint Infection (JI) Panel
IVD reagent kit containing 30 kits.
Details
Device typeMultiple-type osteoarticular 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 acid from multiple types of microorganisms (e.g., bacteria, viruses, parasites) associated with osteoarticular/joint infection in a clinical specimen (typically synovial fluid), using a nucleic acid technique (NAT). This test detects pathogens which may include Clostridium, Klebsiella, and Salmonella bacteria, and the yeast Candida albicans, and is used to aid the diagnosis of infectious arthritis (septic arthritis) and/or prosthetic joint infection.
FDA categoryOrthopedic Infection Microbial Multiplex Nucleic Acid Detection System
Device ID00815381020192
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information