21 CFR 862.1035
§ 862.1035 Albumin test system.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 862.1035, § 862.1035 Albumin test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89040
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.