The IVD functional thyroid marker cluster: FT3, FT4, T3, T4, TSH, Anti-TG, Anti-TPO - Vietnam Registration 240002389/PCBB-HN

30400: VIDAS® TSH is an automated quantitative assay for use on VIDAS® devices to determine the concentration of thyroid-stimulating hormone (TSH) in human serum or plasma (lithium heparin) by enzyme-linked immunofluorescence (ELISA). 30402: VIDAS® FT3 is an automated quantitative assay for use on VIDAS® devices to determine the concentration of free triiodothyronine (FT3) in human serum or plasma (lithium heparin) by enzyme-linked immunofluorescence (ELISA). 30403: VIDAS® T3 is an automated quantitative assay for use on VIDAS® devices to determine the concentration of total triiodothyronine (T3) in human serum or plasma (lithium heparin) by enzyme-linked immunofluorescence (ELISA). It is used to assist in the diagnosis of hyperthyroidism in adults. 30404: VIDAS® T4 is an automated quantitative assay for use on VIDAS® devices to determine the concentration of total thyroxine (T4) in human serum or plasma (lithium heparin) by enzyme-linked immunofluorescence (ELISA). VIDAS® T4 is designed to assist in the diagnosis of thyroid disorders in adults. 30441: VIDAS® TSH3 is an automated highly sensitive quantitative assay for use on VIDAS® devices to determine the concentration of human thyroid-stimulating hormone (TSH) in human serum or plasma (silicon tubes, gel-coated smooth tubes, or lithium heparin tubes) by enzyme-linked immunofluorescence (ELISA). 30459: VIDAS® FT4 (FT4N) is an automated quantitative assay for use on VIDAS® devices to determine the concentration of free thyroxine (FT4) in human serum or plasma (lithium heparin) by enzyme-linked immunofluorescence (ELISA). The measurement of free thyroxine is designed to be used as a diagnostic and monitoring tool for thyroid disorders. 30461: The VIDAS® Anti-TPO test is an automated quantitative assay for use on VIDAS® devices to determine the concentration of anti-thyroid peroxidase (anti-TPO) IgG autoantibodies in human serum or plasma by enzyme-linked immunofluorescence (ELISA). The VIDAS® Anti-TPO test is used to assist in the diagnosis of autoimmune thyroid disorders in adults with clinically apparent or subclinical thyroid dysfunction. 30462: The VIDAS® Anti-Tg test is an automated quantitative assay for use on VIDAS® devices to determine the concentration of anti-thyroglobulin (anti-Tg) IgG autoantibodies in human serum or plasma by enzyme-linked immunofluorescence (ELISA). The VIDAS® Anti-Tg test is designed to assist in the diagnosis of autoimmune thyroid disorders.