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U.S. FDA Medical Device Trypsin Test System Requirements


FDA Medical Device Definition: A trypsin test system is a device intended to measure the activity of trypsin (a pancreatic enzyme important in digestion for the breakdown of proteins) in blood and other body fluids and in feces. Measurements obtained by this device are used in the diagnosis and treatment of pancreatic disease.

Registrar Corp assists Trypsin Test System companies with:

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