LAL · Eas Chromatography, Quinine
Clinical Toxicology · 21 CFR 862.3750 · Class 1
Overview
| Product Code | LAL |
|---|---|
| Device Name | Eas Chromatography, Quinine |
| Regulation | 21 CFR 862.3750 |
| Device Class | Class 1 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
