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Electronic Code of Federal Regulations

e-CFR data is current as of February 21, 2020

Title 21Chapter ISubchapter HPart 864Subpart F → §864.5680


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F—Automated and Semi-Automated Hematology Devices


§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).

[45 FR 60601, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 58 FR 51571, Oct. 4, 1993]

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