Methylmalonic acid (nonquantitative) test system.

21 C.F.R. § 862.1509
in effectEffective: 2024-07-01
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(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 (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

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