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U.S. FDA Medical Device Counter (Beta, Gamma) Requirements

FDA Medical Device Definition: A beta or gamma counter for clinical use is a device intended to detect and count beta or gamma radiation emitted by clinical samples. Clinical samples are prepared by addition of a radioactive reagent to the sample. These measurements are useful in the diagnosis and treatment of various disorders.

Registrar Corp assists Counter (Beta, Gamma) companies with:

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