21 C.F.R. § 660.4 Potency test.
Title 21 - Food and Drugs
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]
Title 21: Food and Drugs
PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
Subpart A—Antibody to Hepatitis B Surface Antigen
§ 660.4 Potency test.
