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BinaxNOW Streptococcus pneumoniae Antigen Card
The BinaxNOW Streptococcus pneumoniae Antigen Card is an in vitro rapid immunochromatographic assay for the detection of Streptococcus pneumoniae antigen in the urineof patients with pneumonia and in the cerebral spinal fluid of patients with meningitis.
Details
Device typeStreptococcus pneumoniae 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 Streptococcus pneumoniae 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 categoryAntisera, All Groups, Streptococcus Spp.
Device ID10811877011061
Single useYes
MRI safetyLabeling does not contain MRI Safety Information