21 CFR § 864.9300 - Automated Coombs test systems.

---
identifier: "/us/cfr/t21/s864.9300"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.9300 - Automated Coombs test systems."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.9300"
section_name: "Automated Coombs test systems."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
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. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---


# 864.9300 Automated Coombs test systems.

(a) *Identification.* An automated Coombs test system is a device used to detect and identify antibodies in patient sera or antibodies bound to red cells. The Coombs test is used for the diagnosis of hemolytic disease of the newborn, and autoimmune hemolytic anemia. The test is also used in crossmatching and in investigating transfusion reactions and drug-induced red cell sensitization.

(b) *Classification.* Class II (performance standards).

[45 FR 60646, Sept. 12, 1980]