[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.5680]

[Page 222]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents
 
       Subpart F--Automated and Semi-Automated Hematology Devices
 
Sec. 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]