SMS, SCREEN MACHINE SYSTEM
Device Facts
| Record ID | K852240 |
|---|---|
| Device Name | SMS, SCREEN MACHINE SYSTEM |
| Applicant | Pandex Laboratories, Inc. |
| Product Code | JZT · Immunology |
| Decision Date | Jun 11, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.4520 |
| Device Class | Class 1 |
Regulatory Classification
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.
