21 CFR § 862.1255 - 2,3-Diphosphoglyceric acid test system.
---
identifier: "/us/cfr/t21/s862.1255"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1255 - 2,3-Diphosphoglyceric acid test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1255"
section_name: "2,3-Diphosphoglyceric acid test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY 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."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---
# 862.1255 2,3-Diphosphoglyceric acid test system.
(a) *Identification.* A 2,3-diphosphoglyceric acid test system is a device intended to measure 2,3-diphosphoglyceric acid (2,3-DPG) in erythrocytes (red blood cells). Measurements of 2,3-diphosphoglyceric acid are used in the diagnosis and treatment of blood disorders that affect the delivery of oxygen by erythrocytes to tissues and in monitoring the quality of stored blood.
(b) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001]