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Code · CFR · Title 21 — Food and Drugs · Part 660 — Additional Standards for Diagnostic Substances for Laboratory Tests · § 660.20

§ 660.20. Blood Grouping Reagent.

91 words·~1 min read·/us/cfr/t21/s§ 660.20·

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(a)Proper name and definition. The proper name of this product shall be Blood Grouping Reagent and it shall consist of an antibody-containing fluid containing one or more of the blood grouping antibodies listed in § 660.28(a)(4).
(b)Source. The source of this product shall be blood, plasma, serum, or protein-rich fluids, such as those derived from stable immunoglobulin-secreting cell lines maintained either in tissue cultures or in secondary hosts. [53 FR 12764, Apr. 19, 1988, as amended at 65 FR 77499, Dec. 12, 2000; 81 FR 38925, June 15, 2016]
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§ 660.20
Blood Grouping Reagent.
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