CFR
- Title 1 - General Provisions
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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.
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