Product code QAW

Device name

Test, Tricyclic Antidepressants, Over The Counter

Medical specialty

Clinical Toxicology

Device class

2

Regulation number

862.3910

Review panel

TX

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

Definition

Intended to measure any of the tricyclic antidepressant drugs in serum or urine.

Source

FDA openFDA device classification dataset