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U.S. FDA Medical Device Cysticercosis Reagents Requirements

FDA Medical Device Definition: Echinococcus spp. serological reagents are devices that consist ofEchinococcus spp. antigens and antisera used in serological tests to identify antibodies toEchinococcus spp. in serum. The identification aids in the diagnosis of echinococcosis, caused by parasitic tapeworms belonging to the genusEchinococcus and provides epidemiological information on this disease. Echinococcosis is characterized by the development of cysts in the liver, lung, kidneys, and other organs formed by the larva of the infecting organisms.

Registrar Corp assists Cysticercosis Reagents companies with:

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