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U.S. FDA Medical Device Copper Test System Requirements

FDA Medical Device Definition: A copper test system is a device intended to measure copper levels in plasma, serum, and urine. Measurements of copper are used in the diagnosis and treatment of anemia, infections, inflammations, and Wilson's disease (a hereditary disease primarily of the liver and nervous system). Test results are also used in monitoring patients with Hodgkin's disease (a disease primarily of the lymph system).

Registrar Corp assists Copper Test System companies with:

  • FDA Copper Test System Establishment Registration
  • FDA Copper Test System Listing
  • FDA Copper Test System Label Requirements and Exceptions
  • FDA Copper Test System Import Information
  • FDA Copper Test System Detentions (Copper Test System Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Copper Test System Manufacturers (Copper Test System Suppliers)
       - Copper Test System Distributors
       - Copper Test System Processors
       - Copper Test System Repackers
       - Copper Test System Relabelers
       - Copper Test System Exporters
       - Copper Test System Importers
For more information about Copper Test System 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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