21 CFR § 862.3750 - Quinine test system.
§ 862.3750 Quinine test system.
(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.