21 CFR § 862.1810 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1810 Vitamin B12 test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(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.

← § 862.1805 Vitamin A test system.§ 862.1815 Vitamin E test system. →