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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, propoxyphene, over the counter
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.
Product CodeQBF
Regulation Number 862.3700
Device Class 2


Premarket Reviews
ManufacturerDecision
W.H.P.M., INC.
  SUBSTANTIALLY EQUIVALENT 1

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