THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY
Device Facts
| Record ID | K936010 |
|---|---|
| Device Name | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY |
| Applicant | Biomerica, Inc. |
| Product Code | DDC · Immunology |
| Decision Date | Jul 18, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5870 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.
