Title 21

SECTION 862.1050

862.1050 Alkaline phosphatase or isoenzymes test system.

§ 862.1050 Alkaline phosphatase or isoenzymes test system.

(a) Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

(b) Classification. Class II.

---