[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: 21CFR660.45]

[Page 128]
 
                        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. 660.45  Labeling.

    In addition to the requirements of Sec. Sec. 610.60, 610.61, and 
809.10 of this chapter, the labeling shall bear the following:
    (a) The ``d and y'' antigen subtype and the source of the product to 
follow immediately the proper name on both the final container label and 
the package label. If the product is intended to identify antibodies to 
the ``r and w'' antigen subtype, the antigen subtype designation shall 
include the ``r and w'' antigen subtype.
    (b) The name of the test method(s) recommended for use of the 
product on the package label and on the final container label, when 
capable of bearing a full label (see Sec. 610.60(a) of this chapter).
    (c) A warning on the package label and on the final container label 
stating that the product is capable of transmitting hepatitis and should 
be handled accordingly.
    (d) The package shall include a package insert providing (1) 
detailed instructions for use, (2) an adequate description of all 
recommended test methods, and (3) warnings as to possible hazards, 
including hepatitis transmitted in handling the product and any 
ancillary reagents and materials accompanying the product.