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McKesson
TEST KIT, MONO WAIVED APPRV F/
Details
Device typeEpstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of heterophile antibodies produced in response to Epstein-Barr virus (EBV) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever. It is not intended to be used for self-testing.
FDA categorySystem, Test, Infectious Mononucleosis
Device ID20612479202775
AvailabilityPrescription
Single useYes
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information