21 C.F.R. § 660.20 Blood Grouping Reagent.
Title 21 - Food and Drugs
(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(d). (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]
Title 21: Food and Drugs
PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
Subpart C—Blood Grouping Reagent
§ 660.20 Blood Grouping Reagent.
