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Test, Propoxyphene, Over The Counter

FDA product code QBF · 1 cleared devices

Class 2 Clinical Toxicology
Regulation
21 CFR 862.3700
Review panel
TX
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2021-08-12 – 2021-08-12

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.

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