Automated heparin analyzer.

21 C.F.R. § 864.5680
in effectEffective: 2024-07-01
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(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).

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