Product code PTH

Device name

Test, Barbiturate, Over The Counter

Medical specialty

Clinical Toxicology

Device class

2

Regulation number

862.3150

Review panel

TX

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

Definition

The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine.

Source

FDA openFDA device classification dataset