21 CFR 862.3035
§ 862.3035 Amikacin test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.3035, § 862.3035 Amikacin test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89243
- Permanent ID
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Full text
(a) Identification. An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.
(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.