21 CFR 862.3750 — Thin Layer Chromatography, Quinine
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3750
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.
Classification Rationale
Class I.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DIK | Thin Layer Chromatography, Quinine | 1 | 0 | 3rd Party |
| LAL | Eas Chromatography, Quinine | 1 | 0 | 3rd Party |
| LAM | High Pressure Liquid Chromatography, Quinine | 1 | 0 | 3rd Party |
