ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS
Device Facts
| Record ID | K930796 |
|---|---|
| Device Name | ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS |
| Applicant | Alko Diagnostic Corp. |
| Product Code | JZX · Immunology |
| Decision Date | Jan 13, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.4830 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Rocket immunoelectrophoresis equipment for clinical use is a device used to perform a specific test on proteins by using a procedure called rocket immunoelectrophoresis. In this procedure, an electric current causes the protein in solution to migrate through agar gel containing specific antisera. The protein precipitates with the antisera in a rocket-shaped pattern, giving the name to the device. The height of the peak (or the area under the peak) is proportional to the concentration of the protein.
