21 CFR § 660.5 Additional Standards for Diagnostic Substances for Laboratory Tests

§ 660.5 Specificity.

Current through Sep 8, 2026 · Read all of Part 660

Each filling of the product shall be specific for antibody to hepatitis B surface antigen, as determined by specificity tests found acceptable by the Director, Center for Biologics Evaluation and Research.

[40 FR 29712, July 15, 1975, as amended at 49 FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, 1990]

← § 660.4 Potency test.§ 660.6 Samples; protocols; official release. →