Find Laws Find Lawyers Free Legal Forms USA State Laws

CFR

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).
Tips