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 / § 866.5425 -2-glycoproteins immunological test system.
§ 866.5425 (a) Identification. An alpha-2-glycoproteins immunolgical test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-glycoproteins (a group of plasma proteins found in the alpha-2 group when subjected to electrophoresis) in serum and other body fluids. Measurement of alpha-2-glycoproteins aids in the diagnosis of some cancers and genetically inherited deficiencies of these plasma proteins.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.