FDA Medical Device Definition: Immunonephelometer equipment for clinical use with its electrical power supply is a device that measures light scattering from antigen-antibody complexes. The concentration of these complexes may be measured by means of reflected light. A beam of light passed through a solution is scattered by the particles in suspension. The amount of light 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 light-scattering value and is used to measure the concentration of antigen-antibody complexes. This generic type of device includes devices with various kinds of light sources, such as laser equipment.
FDA Nephelometer Label Requirements and Exceptions
FDA Nephelometer Import Information
FDA Nephelometer Detentions (Nephelometer Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Nephelometer Manufacturers (Nephelometer Suppliers)
- Nephelometer Distributors
- Nephelometer Processors
- Nephelometer Repackers
- Nephelometer Relabelers
- Nephelometer Exporters
- Nephelometer Importers
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U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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