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 categoryIMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY
Device ID00840239041142
Catalog numberEIA-4114
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information
SizeSerum Diluent
Total Volume8 Milliliter
SizeBiotin Reagent
Total Volume13 Milliliter
Total Volume7 Milliliter
Total Volume20 Milliliter
Total Volume1 Milliliter
SizeWash Solution
SizeSubstrate A
SizeStop Solution
SizeEnzyme Reagent
SizeCalibrators
SizeSubstrate B