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ePlex
ePlex Blood Culture Identification Fungal Pathogen (FP) Cartridge Pouch
Details
Device typeMultiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry: 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 amplification/mass spectrometry method.
FDA categoryFungal Organisms, Nucleic Acid-Based Assay, Gram-Negative Bacteria And Associated Resistance Markers, Gram-Positive Bacteria And Their Resistance Markers
Device ID00857167005283
Catalog numberKT022279
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information