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U.S. FDA Medical Device Globulin Method Turbidimetric Requirements


FDA Medical Device Definition: A globulin test system is a device intended to measure globulins (proteins) in plasma and serum. Measurements of globulin are used in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.

Registrar Corp assists Globulin Method Turbidimetric companies with:

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