21 C.F.R. § 864.7925 Partial thromboplastin time tests.
Title 21 - Food and Drugs
(a) Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway. (b) Classification. Class II (performance standards). [45 FR 60629, Sept. 12, 1980]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages
§ 864.7925 Partial thromboplastin time tests.
