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.
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.
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