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U.S. FDA Medical Device Low-Density Lipoprotein Immunological Test System Requirements: Low-Density Lipoprotein Immunological Test System

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 Low-Density Lipoprotein Immunological Test System companies with:

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




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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


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