21 C.F.R. § 862.1520

Current through October 31, 2024
Section 862.1520 - 5'-Nucleotidase test system
(a)Identification. A 5'-nucleotidase test system is a device intended to measure the activity of the enzyme 5'-nucleotidase in serum and plasma. Measurements of 5'-nucleotidase are used in the diagnosis and treatment of liver diseases and in the differentiations between liver and bone diseases in the presence of elevated serum alkaline phosphatase activity.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9 .

21 C.F.R. §862.1520

52 FR 16122, May 1, 1987, as amended at 65 FR 2307 , Jan. 14, 2000