HUMAN (IGG) SUBCLASS (EIA) KIT
Device Facts
| Record ID | K895600 |
|---|---|
| Device Name | HUMAN (IGG) SUBCLASS (EIA) KIT |
| Applicant | The Binding Site, Ltd. |
| Product Code | DAS · Immunology |
| Decision Date | Nov 8, 1989 |
| 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.
