JZX · Equipment, Rocket Immunoelectrophoresis
Immunology · 21 CFR 866.4830 · Class 1
Overview
| Product Code | JZX |
|---|---|
| Device Name | Equipment, Rocket Immunoelectrophoresis |
| Regulation | 21 CFR 866.4830 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K930796 | ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS | Alko Diagnostic Corp. | Jan 13, 1994 | SESE |
Top Applicants
- Alko Diagnostic Corp. — 1 clearance
