IMMUNOCHEMISTRY SYS. MANUAL MODE
Device Facts
| Record ID | K781006 |
|---|---|
| Device Name | IMMUNOCHEMISTRY SYS. MANUAL MODE |
| Applicant | Beckman Instruments, Inc. |
| Product Code | JZW · Immunology |
| Decision Date | Aug 31, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.4540 |
| Device Class | Class 1 |
Regulatory Classification
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.
