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Anti-Tg Assay kit CLIA

Devices (same UDI-DI)
1
Certificates
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Countries
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Notified Bodies
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Basic Information

Primary DI
06974521003410
Basic UDI-DI Code
B-06974521003410
Reference
SUPM094036
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

This kit is used for in vitro quantitative detection of Anti-thyroglobulin antibody(Anti-Tg) in human serum or plasma samples. Elevated concentrations of serum thyroglobulin antibodies (Tg autoantibodies) are common in thyroiditis caused by some autoimmune diseases. High concentrations of Anti-Tg and Anti-TPO predict chronic lymphocytic infiltrating thyroiditis (Hashimoto's thyroiditis). Anti-Tg detection is very important for the course and differential diagnosis of Hashimoto's thyroiditis. Although concomitant testing for other thyroid antibodies (Anti-TPO, TSH receptor antibody-TRAb) may increase sensitivity, a negative Anti-TG result does not rule out autoimmune disease. Initially elevated antibody titers may turn negative during remission or after a long course of disease, and if antibodies reappear after remission, it may be a relapse. Therefore, the determination of thyroid autoantibodies can be helpful in the diagnosis of certain thyroid disorders, such as Hashimoto's disease, non-toxic goiter and Graves' disease.

CND Nomenclature Codes

Code Description
W0102100303 THYROGLOBULIN AUTOANTIBODY

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