JZS · Electrophoresis Instrumentation
Immunology · 21 CFR 866.4500 · Class 1
Overview
| Product Code | JZS |
|---|---|
| Device Name | Electrophoresis Instrumentation |
| Regulation | 21 CFR 866.4500 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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.
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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K933123 | SYNELISA TG ANTIBODIES/TPO ANTIBODIES | Elias U.S.A., Inc. | Aug 23, 1993 | SESE |
| K812194 | IMMUNODIFFUSION BAND INTENSIFYING FLUID | American Scientific Products | Aug 31, 1981 | SESE |
| K770566 | IMMUNOELECTROPHORESIS PROFILE KIT | Kallestad Laboratories, Inc. | Apr 27, 1977 | SESE |
| K770719 | IMMUNOELECTROFILM KIH | Kallestad Laboratories, Inc. | Apr 26, 1977 | SESE |
| K770718 | STAIN, R-250, COOMASSIE BRILLIANT BLUE | Kallestad Laboratories, Inc. | Apr 26, 1977 | SESE |
| K770150 | ELECTRO IMMUNO ASSAY KIT | Millipore Corp. | Feb 1, 1977 | SESE |
Top Applicants
- Kallestad Laboratories, Inc. — 3 clearances
- American Scientific Products — 1 clearance
- Elias U.S.A., Inc. — 1 clearance
- Millipore Corp. — 1 clearance
