(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]