PTH

Test, Barbiturate, Over The Counter

Product code

PTH

Device name

Test, Barbiturate, Over The Counter

Device class

Class 2

21 CFR

21 CFR 862.3150

Medical specialty

Clinical Toxicology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).