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U.S. FDA Medical Device B. Parapertussis Antigen Requirements

FDA Medical Device Definition: Bordetella spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, used in serological tests to identifyBordetella spp. from cultured isolates or directly from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusBordetella and provides epidemiological information on these diseases.Bordetella spp. cause whooping cough (Bordetella pertussis ) and other similiarly contagious and acute respiratory infections characterized by pneumonitis (inflammation of the lungs).

Registrar Corp assists B. Parapertussis Antigen companies with:

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