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Code · CFR · Title 21 — Food and Drugs · Part 862 — Clinical Chemistry and Clinical Toxicology Devices · § 862.1810

§ 862.1810. Vitamin B12 test system.

41 words·~1 min read·/us/cfr/t21/s§ 862.1810·

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(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.
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