Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES
/ Subpart F - Immunological Test Systems / § 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
§ 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).