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U.S. FDA Medical Device Gastrin Radioimmunoassay Requirements


FDA Medical Device Definition: A gastrin test system is a device intended to measure the hormone gastrin in plasma and serum. Measurements of gastrin are used in the diagnosis and treatment of patients with ulcers, pernicious anemia, and the Zollinger-Ellison syndrome (peptic ulcer due to a gastrin-secreting tumor of the pancreas).

Registrar Corp assists Gastrin Radioimmunoassay companies with:

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