Product code QBF

Device name

Test, Propoxyphene, Over The Counter

Medical specialty

Clinical Toxicology

Device class

2

Regulation number

862.3700

Review panel

TX

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset