QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK
Device Facts
| Record ID | K894538 |
|---|---|
| Device Name | QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK |
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc. |
| Product Code | DBN · Immunology |
| Decision Date | Aug 4, 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.
