Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=sp21.8.866.e&rgn=div6
Timestamp: 2020-07-09 07:51:46
Document Index: 455458506

Matched Legal Cases: ['art 866', '§866', '§866', '§866', '§866', '§866', '§866', '§866', '§866']

Title 21 → Chapter I → Subchapter H → Part 866 → Subpart E
§866.4100 Complement reagent.
§866.4500 Immunoelectrophoresis equipment.
§866.4520 Immunofluorometer equipment.
§866.4540 Immunonephelometer equipment.
§866.4600 Ouchterlony agar plate.
§866.4800 Radial immunodiffusion plate.
§866.4830 Rocket immunoelectrophoresis equipment.
§866.4900 Support gel.
(a) Identification. A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.
[47 FR 50823, Nov. 9, 2001, as amended at 66 FR 38792, July 25, 2001]
(a) Identification. Immunoelectrophoresis equipment for clinical use with its electrical power supply is a device used for separating protein molecules. Immunoelectrophoresis is a procedure in which a complex protein mixture is placed in an agar gel and the various proteins are separated on the basis of their relative mobilities under the influence of an electric current. The separated proteins are then permitted to diffuse through the agar toward a multispecific antiserum, allowing precipitation and visualization of the separate complexes.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 FR 38792, July 25, 2001]
(a) Identification. 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.
(a) Identification. 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.
(a) Identification. An ouchterlony agar plate for clinical use is a device containing an agar gel used to examine antigen-antibody reactions. In immunodiffusion, antibodies and antigens migrate toward each other through gel which originally contained neither of these reagents. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and is immobilized.
[47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38792, July 25, 2001]