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U.S. FDA Medical Device Anti-Streptokinase Requirements

FDA Medical Device Definition: Streptococcus spp. exoenzyme reagents are devices used to identify antibodies toStreptococcus spp. exoenzyme in serum. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.

Registrar Corp assists Anti-Streptokinase companies with:

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