QAW — Test, Tricyclic Antidepressants, Over The Counter Class II

FDA Device Classification

FDA product code QAW covers "Test, Tricyclic Antidepressants, Over The Counter", a Class II medical device regulated under 21 CFR 862.3910. Submissions are reviewed by the Clinical Toxicology panel.

Classification Details

Product Code
QAW
Device Class
Class II
Regulation Number
862.3910
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Definition

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