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Mass Spectrometric, Immunoglobulins (G, A, M, D, E)

FDA product code SGG · 1 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5510
Review panel
IM
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-10-17 – 2025-10-17

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.

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