[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: 21CFR660.5]

[Page 120]
 
                        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 A_Antibody to Hepatitis B Surface Antigen
 
Sec. 660.5  Specificity.

    Each filling of the product shall be specific for antibody to 
hepatitis B surface antigen, as determined by specificity tests found 
acceptable by the Director, Center for Biologics Evaluation and 
Research.

[40 FR 29712, July 15, 1975, as amended at 49 FR 23834, June 8, 1984; 55 
FR 11013, Mar. 26, 1990]