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U.S. FDA Medical Device Uroporphyrin Fluorometric Requirements


FDA Medical Device Definition: A uroporphyrin test system is a device intended to measure uroporphyrin in urine. Measurements obtained by this device are used in the diagnosis and treatment of porphyrias (primarily inherited diseases associated with disturbed porphyrin metabolism), lead poisoning, and other diseases characterized by alterations in the heme pathway

Registrar Corp assists Uroporphyrin Fluorometric companies with:

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