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Code · CFR · Title 21 — Food and Drugs · Part 660 — Additional Standards for Diagnostic Substances for Laboratory Tests · § 660.44

§ 660.44. Specificity.

50 words·~1 min read·/us/cfr/t21/s§ 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. [44 FR 36382, June 22, 1979, as amended at 49 FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, 1990]
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