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e-CFR data is current as of September 17, 2020

Title 21Chapter ISubchapter HPart 862Subpart B → §862.1295


Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems


§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]

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