21 CFR § 660.20 - Blood Grouping Reagent.

---
identifier: "/us/cfr/t21/s660.20"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 660.20 - Blood Grouping Reagent."
title_number: 21
title_name: "Food and Drugs"
section_number: "660.20"
section_name: "Blood Grouping Reagent."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "F"
subchapter_name: "BIOLOGICS"
part_number: "660"
part_name: "ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372; 42 U.S.C. 216, 262, 263, 263a, 264."
cfr_part: "660"
---


# 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(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]