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U.S. FDA Medical Device Histidine Microbiological 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 Microbiological companies with:

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