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Barcode (UDI): 4049016109884
Catalog No: DN 2410-1601-4 M
Product Type: Medical Device
GMDN: Multiple infectious organism/newborn TORCH screen IVD, kit, enzyme immunoassay (EIA) (48194)
Regulation: 98/79/EC
Description: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and/or immunoglobulin M (IgM) antibodies to multiple organisms in a clinical specimen, using an enzyme immunoassay (EIA) method, as part of an antenatal or newborn infection screen, or a TORCH screen. The assay is intended to detect infection by organisms that may include Toxoplasma gondii, Rubella virus, Cytomegalovirus (CMV), Herpes simplex virus 1 (HSV1), Herpes simplex virus 2 (HSV2), human immunodeficiency virus 1 (HIV1), measles virus and/or Treponema pallidum.