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U.S. FDA Medical Device Protein-Bound Iodine Requirements

FDA Medical Device Definition: A protein-bound iodine test system is a device intended to measure protein-bound iodine in serum. Measurements of protein-bound iodine obtained by this device are used in the diagnosis and treatment of thyroid disorders.

Registrar Corp assists Protein-Bound Iodine companies with:

  • FDA Protein-Bound Iodine Establishment Registration
  • FDA Protein-Bound Iodine Listing
  • FDA Protein-Bound Iodine Label Requirements and Exceptions
  • FDA Protein-Bound Iodine Import Information
  • FDA Protein-Bound Iodine Detentions (Protein-Bound Iodine Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Protein-Bound Iodine Manufacturers (Protein-Bound Iodine Suppliers)
       - Protein-Bound Iodine Distributors
       - Protein-Bound Iodine Processors
       - Protein-Bound Iodine Repackers
       - Protein-Bound Iodine Relabelers
       - Protein-Bound Iodine Exporters
       - Protein-Bound Iodine Importers
For more information about Protein-Bound Iodine Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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