21 CFR § 862.3750 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3750 Quinine test system.

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

⚠ 2 pending changes to Part 862

(a) Identification. A quinine test system is a device intended to measure quinine, a fever-reducing and pain-relieving drug intended in the treatment of malaria, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of quinine overdose and malaria.

(b) Classification. Class I.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21450, June 8, 1988; 65 FR 2310, Jan. 14, 2000]

← § 862.3700 Propoxyphene test system.§ 862.3800 Reagents for molecular diagnostic instrument test systems. →