DBK · Fc, Fitc, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5530 · Class 1
Overview
| Product Code | DBK |
|---|---|
| Device Name | Fc, Fitc, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5530 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
