In addition to the requirements of §§ 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 § 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.
Title 21 published on 2014-04-01.
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