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U.S. FDA Medical Device Lipoprotein (A) Test System Requirements


FDA Medical Device Definition: A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Registrar Corp assists Lipoprotein (A) Test System companies with:

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