FDA Product Code JZO: System, Test, Thyroid Autoantibody
FDA product code JZO covers thyroid autoantibody test systems used in the diagnosis of autoimmune thyroid diseases.
These immunoassays detect antibodies against thyroid peroxidase (TPO), thyroglobulin, or TSH receptors in serum, enabling the diagnosis of Hashimoto's thyroiditis, Graves' disease, and other autoimmune thyroid conditions.
JZO devices are Class II medical devices, regulated under 21 CFR 866.5870 and reviewed by the FDA Immunology panel.
Leading manufacturers include Beckman Coulter, Inc., Roche Diagnostics and Siemens Healthcare Diagnostics, Inc..
List of System, Test, Thyroid Autoantibody devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, Test, Thyroid Autoantibody devices (product code JZO). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Immunology FDA review panel. Browse all Immunology devices →