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U.S. FDA Medical Device Porphobilinogen Test System Requirements


FDA Medical Device Definition: A porphobilinogen test system is a device intended to measure porphobilinogen (one of the derivatives of hemoglobin which can make the urine a red color) in urine. Measurements obtained by this device are used in the diagnosis and treatment of porphyrias (primarily inherited diseases associated with disturbed porphyrine metabolism), lead poisoning, and other diseases characterized by alterations in the heme pathway.

Registrar Corp assists Porphobilinogen Test System companies with:

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