Code of Federal Regulations · Section

§ 660.44 — Specificity

21 C.F.R. § 660.44

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Each filling of the product shall be specific for Hepatitis B Surface Antigen as determined by specificity tests found acceptable to the Director, Center for Biologics Evaluation and Research.

21 C.F.R. § 660.43 21 C.F.R. § 660.45

Authorizing Statute

Definitions; generally
21 U.S.C. § 321
Regulations
42 U.S.C. § 216