§ 864.7900. Thromboplastin generation test.
72 words·~1 min read·
/us/cfr/t21/s§ 864.7900·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A thromboplastin generation test is a device used to detect and identify coagulation factor deficiencies and coagulation inhibitors.
(b)Classification. Class I (general controls). This 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 60628, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, 2001]