Registrar Corp

HomeMedical DevicesRegistration & Medical Device ListingsMedical Device Samples › U.S. FDA Strep Pneumoniae DNA-Probe Regulations

U.S. FDA Medical Device Strep Pneumoniae DNA-Probe Requirements


FDA Medical Device Definition: Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases 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 Strep Pneumoniae DNA-Probe companies with:

  • FDA Strep Pneumoniae DNA-Probe Establishment Registration
  • FDA Strep Pneumoniae DNA-Probe Listing
  • FDA Strep Pneumoniae DNA-Probe Label Requirements and Exceptions
  • FDA Strep Pneumoniae DNA-Probe Import Information
  • FDA Strep Pneumoniae DNA-Probe Detentions (Strep Pneumoniae DNA-Probe Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Strep Pneumoniae DNA-Probe Manufacturers (Strep Pneumoniae DNA-Probe Suppliers)
       - Strep Pneumoniae DNA-Probe Distributors
       - Strep Pneumoniae DNA-Probe Processors
       - Strep Pneumoniae DNA-Probe Repackers
       - Strep Pneumoniae DNA-Probe Relabelers
       - Strep Pneumoniae DNA-Probe Exporters
       - Strep Pneumoniae DNA-Probe Importers
For more information about Strep Pneumoniae DNA-Probe 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.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
 
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco