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U.S. FDA Medical Device Hydroxyproline Test System Requirements


FDA Medical Device Definition: A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.

Registrar Corp assists Hydroxyproline Test System companies with:

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