View all text of Subpart H [§ 864.7010 - § 864.7925]
§ 864.7900 - Thromboplastin generation test.
(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.