![]() |
Code of Federal Regulations (Last Updated: July 5, 2024) |
![]() |
Title 21 - Food and Drugs |
![]() |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
![]() |
SubChapter H - Medical Devices |
![]() |
Part 864 - Hematology and Pathology Devices |
![]() |
Subpart H - Hematology Kits and Packages |
§ 864.7525 - Heparin assay.
Latest version.
-
§ 864.7525 Heparin assay.
(a) Identification. A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).
(b) Classification. Class II (performance standards).
[45 FR 60623, Sept. 12, 1980]