Device typeMycoplasma pneumoniae immunoglobulin M (IgM) 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 immunoglobulin M (IgM) antibodies to Mycoplasma 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 categoryEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Device ID00840733101762
Catalog number709030
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information