AMINOGLYCOSIDE CONTROLS
Device Facts
| Record ID | K761156 |
|---|---|
| Device Name | AMINOGLYCOSIDE CONTROLS |
| Applicant | Supelco, Inc. |
| Product Code | DAS · Immunology |
| Decision Date | Dec 9, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5530 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An immunoglobulin G (Fc fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming abnormalities, e.g., gamma heavy chain disease.
