[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: 21CFR660.22]

[Page 122]
 
                        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 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 (HFM-
407) (see mailing addresses in Sec. 600.2 of this chapter), and shall 
be used as described in the accompanying package insert for determining 
the potency of Blood Grouping Reagents.

[53 FR 12764, Apr. 19, 1988, as amended at 67 FR 9587, Mar. 4, 2002; 70 
FR 14985, Mar. 24, 2005]