Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 862  /  Sec. 862.1509 Methylmalonic acid (nonquantitative) test system.

(a) Identification. A methylmalonic acid (nonquantitative) test system is a device intended to identify methylmalonic acid in urine. The identification of methylmalonic acid in urine is used in the diagnosis and treatment of methylmalonic aciduria, a heritable metabolic disorder which, if untreated, may cause mental retardation.

(b) Classification. Class II.