View all text of Subpart F [§ 864.5200 - § 864.5950]
§ 864.5680 - Automated heparin analyzer.
(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).