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U.S. FDA Medical Device Total Protein Turbidimetric Requirements


FDA Medical Device Definition: A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

Registrar Corp assists Total Protein Turbidimetric companies with:

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