[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: 21CFR660.40]

[Page 127]
 
                        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 E_Hepatitis B Surface Antigen
 
Sec. 660.40  Hepatitis B Surface Antigen.

    Source: 44 FR 36382, June 22, 1979, unless otherwise noted.


    (a) Proper name and definition. The proper name of this product 
shall be Hepatitis B Surface Antigen (HBsAg), which shall consist of a 
serum or tissue preparation containing one or more subtypes of the 
Hepatitis B Surface Antigen.
    (b) Source. The source of the product shall be blood, plasma, serum, 
or tissue, obtained aseptically from nonhuman primates that have met the 
applicable requirements of Sec. 600.11 of this chapter, or from human 
donors whose blood is positive for the Hepatitis B Surface Antigen.