[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR660.53]

[Page 119]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS--Table of Contents
 
                     Subpart F--Anti-Human Globulin
 
Sec. 660.53  Controls for serological procedures.

    Red blood cells sensitized with complement shall be tested with 
appropriate positive and negative control antisera. All tests shall be 
performed in accordance with serological testing procedures approved by 
the Director, Center for Biologics Evaluation and Research (HFB-1), Food 
and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892.

(Approved by the Office of Management and Budget under control number 
0910-0208)

[50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985; 51 
FR 15611, Apr. 25, 1986; 55 FR 11014, Mar. 26, 1990]

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