[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: 21CFR660.50]

[Page 119]
 
                        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. 660.50  Anti-Human Globulin.


    (a) Proper name and definition. The proper name of this product 
shall be Anti-Human Globulin which shall consist of one or more 
antiglobulin antibodies identified in Sec. 660.55(d) and be prepared by 
a method demonstrated to yield consistently a sterile product.
    (b) Source. The source of this product shall be either serum from 
animals immunized with one or more human serum globulins or protein-rich 
fluids derived from stable immunoglobulin-secreting cell lines 
maintained either in tissue cultures or in secondary hosts.

[50 FR 5579, Feb. 11, 1985]

    Effective Date Note: At 65 FR 77499, Dec. 12, 2000, Sec. 660.50(a) 
was amended by removing the words ``and be prepared by a method 
demonstrated to yield consistently a sterile product'', effective June 
11, 2001.