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U.S. FDA Medical Device Osmotic Fragility Testing Requirements


FDA Medical Device Definition: An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions.

Registrar Corp assists Osmotic Fragility Testing companies with:

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