[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR660.54]

[Page 130]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 660_ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS--
 
                      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:
    (a) Potency tests for determining anti-IgG and anti-complement 
activity.
    (b) Specificity tests, tests for heterospecific antibodies, and 
additional tests for nonspecific properties.

[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; 67 FR 9587, Mar. 4, 
2002; 70 FR 14986, Mar. 24, 2005]