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


FDA Medical Device Definition: serological reagents are devices that consist of antigens and antisera used in serological tests to identifySalmonella spp. from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifySalmonella spp. directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of salmonellosis caused by bacteria belonging to the genusSalmonella and provides epidemiological information on this disease. Salmonellosis is characterized by high grade fever ("enteric fever"), severe diarrhea, and cramps

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

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