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U.S. FDA Medical Device Lectins & Protectins Requirements

FDA Medical Device Definition: Lectins and protectins are proteins derived from plants and lower animals that cause cell agglutination in the presence of certain antigens. These substances are used to detect blood group antigens for in vitro diagnostic purposes.

Registrar Corp assists Lectins & Protectins companies with:

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