Device typeMultiple-genus gastrointestinal disease-associated bacteria 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 bacteria genera associated with gastrointestinal diseases, in a clinical specimen, using a nucleic acid technique (NAT). Bacteria detected may include Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Bacillus and/or Vibrio species.
FDA categoryGastrointestinal pathogen panel multiplex nucleic acid-based assay system
Device ID00382904438128
Catalog number443812
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information