21 CFR 862.1810 — Radioassay, Vitamin B12

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1810

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
CDDRadioassay, Vitamin B122783rd Party
LIGRadioassay, Intrinsic Factor Blocking Antibody283rd Party
Innolitics

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