FIAX IGG TEST
Device Facts
| Record ID | K832821 |
|---|---|
| Device Name | FIAX IGG TEST |
| Applicant | Intl. Diagnostic Technology |
| Product Code | DFI · Immunology |
| Decision Date | Oct 14, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5860 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A total spinal fluid immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the total protein in cerebrospinal fluid. Measurement of spinal fluid proteins may aid in the diagnosis of multiple sclerosis and other diseases of the nervous system.
