 |
Code of Federal Regulations (Last Updated: July 5, 2024) |
 |
Title 21 - Food and Drugs |
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
SubChapter H - Medical Devices |
|
Part 862 - Clinical Chemistry and Clinical Toxicology Devices |
|
Subpart B - Clinical Chemistry Test Systems |
§ 862.1509 - Methylmalonic acid (nonquantitative) test system.
Latest version.
-
§ 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 (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.
[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]