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U.S. FDA Medical Device Shigella Spp. DNA-Reagents Requirements


FDA Medical Device Definition: serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), used in serological tests to identifyShigella spp. from cultured isolates. The identification aids in the diagnosis of shigellosis caused by bacteria belonging to the genusShigella and provides epidemiological information on this disease. Shigellosis is characterized by abdominal pain, cramps, diarrhea, and fever.

Registrar Corp assists Shigella Spp. DNA-Reagents companies with:

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