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

862.1580 - Phosphorus (inorganic) test system.

  (a) Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine.

Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

  (b) Classification. Class I.