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InstaStrip Fentanyl Rapid Test (Urine) is intended for the qualitative detection of fentanyl in human urine at the cutoff value of 1.0 ng/mL. The test is intended for over-the-counter (OTC) use. The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. The InstaStrip Fentanyl Dipstick Test (Urine) is intended for the qualitative detection of fentanyl in human urine at the cutoff value of 1.0 ng/mL. The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

InstaStrip Fentanyl Test is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each InstaStrip Fentanyl Test device consists of a Test Strip, a Test Tube, a Dropper and a package insert. Each Test Strip is sealed with sachets of desiccant in an aluminum pouch.