862.1810 Vitamin B12 test system.§ 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.