21 CFR § 862.3030 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3030 Acetaminophen test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(a) Identification. An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

(b) Classification. Class II.

← § 862.2920 Plasma viscometer for clinical use.§ 862.3035 Amikacin test system. →