21 CFR § 660.44 Additional Standards for Diagnostic Substances for Laboratory Tests

§ 660.44 Specificity.

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

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.

[44 FR 36382, June 22, 1979, as amended at 49 FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, 1990]

← § 660.43 Potency test.§ 660.45 Labeling. →