CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES > SUBPART F—Immunological Test Systems (§866.5040 to §866.5910) > 866.5620—Alpha -2-macroglobulin immunological test system.

866.5620—Alpha -2-macroglobulin immunological test system.

(a) Identification. An alpha -2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha -2-macroglobulin (a serum protein) in plasma. Measurement of alpha -2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.
(b) Classification. Class II (performance standards).