21 CFR 862.1255
§ 862.1255 2,3-Diphosphoglyceric acid test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1255, § 862.1255 2,3-Diphosphoglyceric acid test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89091
- Permanent ID
ys:prov:89091@1- SHA-256
f651bae72259a177889dbcabf1638d9f1aa6956428c0b2d7f67a67eef838ce5f
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.