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U.S. FDA Medical Device Streptolysin O 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 Streptolysin O companies with:

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