21 CFR 866.5870 — Thyroglobulin, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5870
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DDC | Thyroglobulin, Antigen, Antiserum, Control | 2 | 13 | 3rd Party |
| DDJ | Thyroglobulin, Fitc, Antigen, Antiserum, Control | 2 | 0 | 3rd Party |
| DDL | Thyroglobulin, Rhodamine, Antigen, Antiserum, Control | 2 | 0 | 3rd Party |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 2 | 22 | 3rd Party |
| JZO | System, Test, Thyroid Autoantibody | 2 | 92 | 3rd Party |
