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Device typeBeta-haemolytic Group A Streptococcus antigen 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 antigens from Group A beta-haemolytic Streptococcus bacteria 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. It is not intended to be used for self-testing.

FDA categorySystem, Test, Infectious Mononucleosis

Device ID15099590625900

Catalog number395100

AvailabilityPrescription

Single useYes

MRI safetyLabeling does not contain MRI Safety Information