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U.S. FDA Medical Device Ouchterlony Agar Plates Requirements


FDA Medical Device Definition: An ouchterlony agar plate for clinical use is a device containing an agar gel used to examine antigen-antibody reactions. In immunodiffusion, antibodies and antigens migrate toward each other through gel which originally contained neither of these reagents. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and is immobilized.

Registrar Corp assists Ouchterlony Agar Plates companies with:

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