21 CFR § 864.7925 - Partial thromboplastin time tests.

---
identifier: "/us/cfr/t21/s864.7925"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.7925 - Partial thromboplastin time tests."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.7925"
section_name: "Partial thromboplastin time tests."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---


# 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]