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§ 862.1810 Vitamin B<sub>12</sub> test system.

21 CFR 862.1810

Citation21 CFR 862.1810
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 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.