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Alethia™ Pertussis External Control Kit
The Alethia Pertussis External Control Kit contains Positive Control Reagent for use with the Alethia Pertussis DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia Assay Control/Negative Control reagent provided in the Pertussis kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors.
Details
Device typeBordetella pertussis nucleic acid IVD, control: A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from Bordetella pertussis bacteria in a clinical specimen.
FDA categoryBordetella Pertussis Dna Assay System
Device ID00840733102141
Catalog number479930
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information