[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: 21CFR864.7060]

[Page 224]
 
                        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 H--Hematology Kits and Packages
 
Sec. 864.7060  Antithrombin III assay.

    (a) Identification. An antithrombin III assay is a device that is 
used to determine the plasma level of antithrombin III (a substance 
which acts with the anticoagulant heparin to prevent coagulation). This 
determination is used to monitor the administration of heparin in the 
treatment of thrombosis. The determination may also be used in the 
diagnosis of thrombophilia (a congenital deficiency of antithrombin 
III).
    (b) Classification. Class II (performance standards).

[45 FR 60609, Sept. 12, 1980]