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U.S. FDA Medical Device Urinary Protein Test System Requirements


FDA Medical Device Definition: A methylmalonic acid (nonquantitative) test system is a device intended to identify methylmalonic acid in urine. The identification of methylmalonic acid in urine is used in the diagnosis and treatment of methylmalonic aciduria, a heritable metabolic disorder which, if untreated, may cause mental retardation

Registrar Corp assists Urinary Protein Test System companies with:

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