21 CFR § 660.50 - Anti-Human Globulin.

---
identifier: "/us/cfr/t21/s660.50"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 660.50 - Anti-Human Globulin."
title_number: 21
title_name: "Food and Drugs"
section_number: "660.50"
section_name: "Anti-Human Globulin."
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"
---


# 660.50 Anti-Human Globulin.

(a) *Proper name and definition.* The proper name of this product shall be Anti-Human Globulin which shall consist of one or more antiglobulin antibodies identified in § 660.55(a)(4).

(b) *Source.* The source of this product shall be either serum from animals immunized with one or more human serum globulins or protein-rich fluids derived from stable immunoglobulin-secreting cell lines maintained either in tissue cultures or in secondary hosts.

[50 FR 5579, Feb. 11, 1985, as amended at 65 FR 77499, Dec. 12, 2000; 81 FR 38928, June 15, 2016]