Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Immunoglobulin G subclass (IgG subclass) IVD kits using nephelometry or turbidimetry measure specific antibody levels in patient samples. Clinically, these tests help diagnose immune deficiencies, monitor autoimmune diseases, or assess responses to infections by quantifying IgG1, IgG2, IgG3, or IgG4 levels in serum or plasma.

These kits are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820. They are usually supplied as reagent kits, requiring calibration and maintenance per manufacturer instructions, and are intended for use in clinical laboratories with appropriate instrumentation.