21 CFR 862.3030 — Colorimetry, Acetaminophen

Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3030

Identification

An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
LDPColorimetry, Acetaminophen2363rd Party
Innolitics

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