[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: 21CFR660.54]

[Page 120]
 
                        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. 660.54  Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.

    The following tests shall be performed using test procedures 
approved by the Director, Center for Biologics Evaluation and Research 
(HFB-1), Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 
20892:
    (a) Potency tests for determining anti-IgG and anti-complement 
activity.
    (b) Specificity tests, tests for heterospecific antibodies, and 
additional tests for nonspecific properties.

(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]