[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: 21CFR660.20]

[Page 110]
 
                        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. 660.20  Blood Grouping Reagent.

    Source: 53 FR 12764, Apr. 19, 1988, unless otherwise noted.


    (a) Proper name and definition. The proper name of this product 
shall be Blood Grouping Reagent and it shall consist of an antibody-
containing fluid prepared by a method demonstrated to yield consistently 
a sterile product and containing one or more of the blood grouping 
antibodies listed in Sec. 660.28(d).
    (b) Source. The source of this product shall be blood, plasma, 
serum, or protein-rich fluids, such as those derived from stable 
immunoglobulin-secreting cell lines maintained either in tissue cultures 
or in secondary hosts.

    Effective Date Note: At 65 FR 77499, Dec. 12, 2000, Sec. 660.20(a) 
was amended by removing the words ``prepared by a method demonstrated to 
yield consistently a sterile product and'', effective June 11, 2001.