21 CFR 862.1810 - Vitamin B12 test system.

Regulations last checked for updates: May 07, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart B [§ 862.1020 - § 862.1840]

§ 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.

authority: 21 U.S.C. 351,360,360c,360e,360j,360l,371

source: 52 FR 16122, May 1, 1987, unless otherwise noted.

cite as: 21 CFR 862.1810