21 C.F.R. § 864.5680 Automated heparin analyzer.
Title 21 - Food and Drugs
(a) Identification. An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation. (b) Classification. Class II (special controls). [45 FR 60601, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 58 FR 51571, Oct. 4, 1993]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F—Automated and Semi-Automated Hematology Devices
§ 864.5680 Automated heparin analyzer.