1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
  6. Subpart B - Clinical Chemistry Test Systems
  7. 21 CFR § 862.1035
21 CFR § 862.1035
Albumin test system
June 25, 2020
CFR

(a) Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

(b) Classification. Class II.

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§ 862.1050 Alkaline phosphatase or isoenzymes test system

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