21 CFR § 862.1295 - Folic acid test system.

---
identifier: "/us/cfr/t21/s862.1295"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1295 - Folic acid test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1295"
section_name: "Folic 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"
---


# 862.1295 Folic acid test system.

(a) *Identification.* A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.

(b) *Classification.* Class II.

[52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988]