21 CFR 862.1295 — Acid, Folic, Radioimmunoassay

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1295

Identification

A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
CGNAcid, Folic, Radioimmunoassay2643rd Party
Innolitics

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