Product Specifications
| Specification | Details |
| Manufacturer / Brand | Wondfo USA Co., Ltd. / SAFElife™ T-Dip® |
| Manufacturer # / SKU | WKRA-114 |
| Active Target Analyte | Kratom (KRA) — Mitragynine / Mitragynine Metabolites |
| Detection Cutoff Level | 300 ng/mL |
| Test Matrix | Human Urine |
| Regulatory Status | Forensic Use Only (FUO) (Not CLIA-Waived / Not FDA 510k Cleared) |
| Storage Temperature | 2°C to 30°C (36°F to 86°F) — Do Not Freeze |
| Packaging | 25 Tests per Box (Individually Pouched with Desiccant) |
| Result Window Validity | Read at 5 Minutes (Stable up to 4 Hours) |
Key Features & Clinical Applications
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High-Sensitivity Screening: Utilizes a precise competitive binding immunoassay format calibrated to a standard 300 ng/mL cutoff, minimizing false positives from unrelated botanical compounds.
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Streamlined T-Dip® Design: Engineered for quick “dip-and-read” operation; the narrow card format requires minimal urine sample volumes and optimizes counter workspace.
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Easy Visual Interpretation: Simple line-based architecture where two lines (Control and Test) indicate a negative result and a single line (Control only) indicates a presumptive positive screening.
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Extended Integrity Window: Unlike standard lateral flow tests that degrade quickly, T-Dip® results remain stable and valid for analysis for up to 4 hours post-activation.
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Forensic & Corporate Utility: Ideal for zero-tolerance screening environments, behavioral health clinics, and emergency toxicology assessments.
⚠️ Regulatory Status Warning: Forensic Use Only. This device is classified as an FUO product. It is not cleared by the FDA for clinical diagnostic utility in therapeutic drug monitoring or medical diagnosis within the United States.
⚠️ Presumptive Status Note: This assay provides a preliminary, qualitative screening result only. All positive results must be verified using a more specific alternative chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) or LC/MS.
⚠️ Handling Protocol: Bring the pouched test card to room temperature before tearing open. Do not submerge the card past the maximum fill line (MAX) printed on the dip strip.




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