IMMUNODIFFUSION BAND INTENSIFYING FLUID
Device Facts
| Record ID | K812194 |
|---|---|
| Device Name | IMMUNODIFFUSION BAND INTENSIFYING FLUID |
| Applicant | American Scientific Products |
| Product Code | JZS · Immunology |
| Decision Date | Aug 31, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.4500 |
| Device Class | Class 1 |
Regulatory Classification
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.
