21 CFR 660.20 - Blood Grouping Reagent.

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§ 660.20 Blood Grouping Reagent.
(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 published on 2014-04-01.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2015-05-22; vol. 80 # 99 - Friday, May 22, 2015
    1. 80 FR 29842 - Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 23, 2016.
      21 CFR Parts 606, 610, 630, 640, 660, and 820

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 660 after this date.

  • 2015-05-22; vol. 80 # 99 - Friday, May 22, 2015
    1. 80 FR 29842 - Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 23, 2016.
      21 CFR Parts 606, 610, 630, 640, 660, and 820