DeviceClearance

Product code SGG— Immunology

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser

Classification name
Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
Device class
Class 2
Regulation
21 CFR 866.5510
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SGG under 21 CFR 866.5510, via openFDA

Market context for product code SGG

FDA has cleared 1 device under product code SGG, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SGG

Recent clearances under product code SGG

Data sourced from openFDA. This site is unofficial and independent of the FDA.