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Title 21 Part 866 → Subpart F → §866.5130

Title 21 → Chapter I → Subchapter H → Part 866 → Subpart F → §866.5130

Electronic Code of Federal Regulations e-CFR

Title 21 Part 866 → Subpart F → §866.5130

e-CFR data is current as of January 27, 2020

Title 21Chapter ISubchapter HPart 866Subpart F → §866.5130


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems


§866.5130   Alpha-1-antitrypsin immunological test system.

(a) Identification. An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

(b) Classification. Class II (performance standards).