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BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests
IVD reagent kit containing 30 tests.
Details
Device typeMultiple-type respiratory 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 (bacteria, fungi and/or viruses) associated with respiratory disease in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, influenza A, respiratory syncytial viruses A and B, rhinovirus, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, and/or enterovirus.
FDA categoryReagents, 2019-Novel Coronavirus Nucleic Acid
Device ID00815381020239
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information