§ 864.7275. Euglobulin lysis time tests.
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/us/cfr/t21/s§ 864.7275·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A euglobulin lysis time test is a device that measures the length of time required for the lysis (dissolution) of a clot formed from fibrinogen in the euglobulin fraction (that fraction of the plasma responsible for the formation of plasmin, a clot lysing enzyme). This test evaluates natural fibrinolysis (destruction of a blood clot after bleeding has been arrested). The test also will detect accelerated fibrinolysis.
(b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. [45 FR 60612, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]