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) > 862.1020—Acid phosphatase (total or prostatic) test system.

862.1020—Acid phosphatase (total or prostatic) test system.

(a) Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.
(b) Classification. Class II.