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U.S. FDA Medical Device Lipoprotein Test System Requirements


FDA Medical Device Definition: A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

Registrar Corp assists Lipoprotein Test System companies with:

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