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e-CFR data is current as of February 24, 2021 |
Title 21 → Chapter I → Subchapter H → Part 862 → Subpart B → §862.1810 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§862.1810 Vitamin B12 test system.
(a) Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
(b) Classification. Class II.