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U.S. FDA Medical Device Histidine Chromatographic Requirements


FDA Medical Device Definition: A histidine test system is a device intended to measure free histidine (an amino acid) in plasma and urine. Histidine measurements are used in the diagnosis and treatment of hereditary histidinemia characterized by excess histidine in the blood and urine often resulting in mental retardation and disordered speech development.

Registrar Corp assists Histidine Chromatographic companies with:

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