SGG — Mass Spectrometric, Immunoglobulins (G, A, M, D, E) Class II
Classification Details
- Product Code
- SGG
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
The test system is intended for the (semi-)quantitative or quantitative determination of monoclonal immunoglobulins (M-proteins) and/or the identification of Immunoglobulin isotype of M-proteins in human specimens by mass spectrometric methods.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250159 | binding site group | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | October 17, 2025 |