Total immunoglobulin G (IgG total) IVD, antibody

This category includes in vitro diagnostic (IVD) devices designed to detect and measure total immunoglobulin G (IgG) in clinical specimens such as blood or serum. These devices use antibodies that bind specifically to IgG to support the assessment of immune status, infection, or autoimmune conditions.

Such IVD reagents are regulated as diagnostic tools and are intended for use in laboratory settings by trained professionals. They are supplied as kits, reagents, or systems and must meet performance and safety requirements for their intended use in detecting IgG without implying a specific regulatory class or approval status.