Code of Federal Regulations · Section

§ 862.1810 — Vitamin B12 Test System

21 C.F.R. § 862.1810

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(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.

21 C.F.R. § 862.1805 21 C.F.R. § 862.1815

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