[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: 21CFR660.22]

[Page 111]
 
                        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 C--Blood Grouping Reagent
 
Sec. 660.22  Potency requirements with reference preparations.

    (a) Potency requirements. Products for which reference Blood 
Grouping Reagents are available shall have a potency titer value at 
least equal to that of the reference preparation.
    (b) Reference preparations. Reference Blood Grouping Reagents shall 
be obtained from the Center for Biologics Evaluation and Research (HFN-
890), Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 
20892, and shall be used as described in the accompanying package insert 
for determining the potency of Blood Grouping Reagents.

(Information collection requirements approved by the Office of 
Management and Budget under control number 0910-0209)