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Blood Grouping Reagent
Law
CFR 21
Food and Drugs
Food and Drug Administration, Department of Health and Human Services
Biologics
Additional Standards for Diagnostic Substances for Laboratory Tests
Blood Grouping Reagent
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Section
660.20
Blood Grouping Reagent.
Section
660.21
Processing.
Section
660.22
Potency requirements with reference preparations.
Section
660.25
Potency tests without reference preparations.
Section
660.26
Specificity tests and avidity tests.
Section
660.28
Labeling.