Device typeMultiple thyroid antibody IVD, kit, enzyme immunoassay (EIA): A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to the thyroid gland and/or specific products of thyroid gland metabolism in a clinical specimen, using an enzyme immunoassay (EIA) method. This test detects autoantibodies directed at antigens such as thyroid gland tissue, thyroglobulin, and thyroid peroxidase (TPO) [known as anti-microsomal antibody] to aid in the diagnosis of autoimmune thyroid diseases such as autoimmune thyroiditis (Hashimoto’s disease) and Graves’ disease.
FDA categoryTHYROGLOBULIN, ANTIGEN, ANTISERUM, CONTROL
Device ID00840239041104
Catalog numberEIA-4110
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information
Total Volume20 Milliliter
SizeWash Solution
SizeCalibrators
Total Volume13 Milliliter
SizeStop Solution
Total Volume1 Milliliter
SizeSubstrate B
SizeBiotin Reagent
SizeSubstrate A
Total Volume7 Milliliter
SizeEnzyme Reagent
Total Volume8 Milliliter
SizeSerum Diluent