21 CFR 660.4 - Potency test.

Regulations last checked for updates: May 01, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart A [§ 660.1 - § 660.6]

§ 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]

authority: 21 U.S.C. 321,331,351,352,353,355,360,360c,360d,360h,360i,371,372; 42 U.S.C. 216,262,263,263a,264

cite as: 21 CFR 660.4