[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: 21CFR660.4]

[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. 660.4  Potency test.

    To be satisfactory for release, each filling of Antibody to 
Hepatitis B Surface Antigen shall be tested against the Reference 
Hepatitis B Surface Antigen Panel and shall be sufficiently potent to 
detect the antigen in the appropriate sera of the reference panel by all 
test methods recommended by the manufacturer in the package insert.

[40 FR 29711, July 15, 1975]