21 C.F.R. § 866.5510

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).

21 C.F.R. §866.5510