RAICHEM(TM) SPIA(TM) IGG REAGENTS
Device Facts
| Record ID | K894416 |
|---|---|
| Device Name | RAICHEM(TM) SPIA(TM) IGG REAGENTS |
| Applicant | Reagents Applications, Inc. |
| Product Code | KTO · Immunology |
| Decision Date | Aug 1, 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.
