SGG · Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | SGG |
|---|---|
| Device Name | Mass Spectrometric, Immunoglobulins (G, A, M, D, E) |
| Regulation | 21 CFR 866.5510 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group , Ltd. | Oct 17, 2025 | SESE |
Top Applicants
- The Binding Site Group , Ltd. — 1 clearance
