Current through September 30, 2024
Section 866.5510 - Immunoglobulins A, G, M, D, and E immunological test system(a)Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)Classification. Class II (performance standards).