TITAN GE/IEPLATE
Device Facts
| Record ID | K831603 |
|---|---|
| Device Name | TITAN GE/IEPLATE |
| Applicant | Helena Laboratories |
| Product Code | JZR · Immunology |
| Decision Date | Jul 7, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.4900 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A support gel for clinical use is a device that consists of an agar or agarose preparation that is used while measuring various kinds of, or parts of, protein molecules by various immunochemical techniques, such as immunoelectrophoresis, immunodiffusion, or chromatography.
