21 CFR 862.3830 — Gas Chromatography, Salicylate

Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3830

Identification

A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
DIMGas Chromatography, Salicylate203rd Party
DJEThin Layer Chromatography, Salicylate213rd Party
DKJColorimetry, Salicylate2293rd Party
DMXLiquid Chromatography, Salicylate203rd Party
DNCStrip, Paper, Salicylate203rd Party
Innolitics

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