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52 FR 16122, May 1, 1987, unless otherwise noted.
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Subscribe to: 21 CFR 862.1810
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Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.
(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.