JZO · Class II · 21 CFR 866.5870

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..

92
Total
92
Cleared
104d
Avg days
1976
Since
92 devices
49–72 of 92
No devices found for this product code.