Device typeMultiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA): A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with liver disease in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at liver-kidney microsome 1 protein (anti-LKM1), smooth muscle (anti-SMA), F-Actin, soluble liver antigen (SLA), Sp-100 protein, glycoprotein-210 (gp210), lamin B receptor (LBR) and also liver cytosol specific antibody type 1 (anti-LC1) and/or antimitochondrial antibodies (AMA).
FDA categoryAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control, Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis, Autoantibodies, Nuclear Body Protein, Sp100, Autoantibodies, Nuclear Pore Glycoprotein Gp210, Autoantibodies,Lkm-1(Liver/Kidney Microsome,Type 1)
Device ID04049016124894
Single useYes
MRI safetyLabeling does not contain MRI Safety Information