Device typeMultiple-type gastrointestinal 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 associated with gastrointestinal disease, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.
FDA categoryGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Device ID00815381020116
Catalog numberRFIT-ASY-0104
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information