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U.S. FDA Medical Device Lipase 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 Lipase Test System companies with:

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