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U.S. FDA Medical Device Fluorometer Requirements


FDA Medical Device Definition: Immunofluorometer equipment for clinical use with its electrical power supply is a device used to measure the fluorescence of fluorochrome-labeled antigen-antibody complexes. The concentration of these complexes may be measured by means of reflected light. A beam of light is passed through a solution in which a fluorochrome has been selectively attached to serum protein antibody molecules in suspension. The amount of light emitted by the fluorochrome label is detected by a photodetector, which converts light energy into electrical energy. The amount of electrical energy registers on a readout system such as a digital voltmeter or a recording chart. This electrical readout is called the fluorescence value and is used to measure the concentration of antigen-antibody complexes.

Registrar Corp assists Fluorometer companies with:

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