Product code QBK

Device name

Meprobamate Test System

Medical specialty

Clinical Toxicology

Device class

2

Regulation number

862.3590

Review panel

TX

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

Definition

A meprobamate test system is a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally-related drug compounds (e.g., prodrugs).

Source

FDA openFDA device classification dataset