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U.S. FDA Medical Device B. Pertussis 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. Pertussis Antigen companies with:

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