[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: 21CFR660.44]

[Page 117]
 
                        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 E--Hepatitis B Surface Antigen
 
Sec. 660.44  Specificity.

    Each filling of the product shall be specific for Hepatitis B 
Surface Antigen as determined by specificity tests found acceptable to 
the Director, Center for Biologics Evaluation and Research.

[44 FR 36382, June 22, 1979, as amended at 49 FR 23834, June 8, 1984; 55 
FR 11013, Mar. 26, 1990]