The information on this page is current as of April 1 2015.
For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
PART 862 -- CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B--Clinical Chemistry Test Systems
(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.
Page Last Updated: 08/21/2015
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