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Electronic Code of Federal Regulations

e-CFR data is current as of November 15, 2019

Title 21Chapter ISubchapter HPart 866Subpart F → §866.5620


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


§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).

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