FLOR. CONJUG. HUMAN FAB FRAGMENT
Device Facts
| Record ID | K770670 |
|---|---|
| Device Name | FLOR. CONJUG. HUMAN FAB FRAGMENT |
| Applicant | Kent Laboratories, Inc. |
| Product Code | DFK · Immunology |
| Decision Date | Apr 28, 1977 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5520 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).
