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e-CFR data is current as of October 22, 2020

Title 21Chapter ISubchapter HPart 864Subpart H → §864.7925


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages


§864.7925   Partial thromboplastin time tests.

(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]

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