QBF

Test, Propoxyphene, Over The Counter

Product code

QBF

Device name

Test, Propoxyphene, Over The Counter

Device class

Class 2

21 CFR

21 CFR 862.3700

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 propoxyphene test is an in vitro diagnostic test for the qualitative detection of propoxyphene in human urine. The test is intended for over-the-counter use as the first step in a two step process to provide consumers with information concerning the presence or absence of propoxyphene in a urine sample.

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