CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES > SUBPART B—Clinical Chemistry Test Systems (§862.1020 to §862.1825) > 862.1520—5′-Nucleotidase test system.

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.

Code of Federal Regulations

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