FDA-cleared, CLIA-waived dipstick test for qualitative detection of fentanyl in human urine at 1 ng/mL cutoff. OTC-compliant device suitable for rapid screening in clinical and point-of-care settings.
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United States
Instanosis enables rapid and portable detection and quantitation of extremely low concentrations of biomarkers across many diseases. The first-of-its-kind technology platforms are hundreds of times more sensitive than state-of-the-art at much lower cost, leading to accurate and instantly actionable results and cost savings for research, clinical trials, disease diagnosis and monitoring.
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Co-Innovation Biotech Co., Ltd · China
FDA-cleared (K231904) lateral flow immunoassay achieving over 99% accuracy for fentanyl detection in urine at 1 ng/mL cutoff concentration. Used for drug screening and toxicology applications.
Famwell · United States
FDA 510(k) cleared and CLIA waived rapid drug screening test for fentanyl and its primary metabolite norfentanyl. Delivers results in 5 minutes using urine specimens with cut-off levels of 1 ng/mL for fentanyl and 5 ng/mL for norfentanyl. Suitable for point-of-care and over-the-counter use with 24-month shelf life.
Wondfo USA Co., Ltd. · United States
A rapid toxicology test available in cassette and dip card formats for fentanyl detection in urine samples. Authorized for Canadian distribution for harm reduction and safety monitoring.
HANGZHOU CLONGENE BIOTECH CO., LTD · China
A lateral flow immunochromatographic assay for the qualitative detection of Fentanyl in human urine at the cut off concentration of 1.0 ng/mL.
Wondfo USA Co., Ltd. · United States
A rapid urine test available in cassette and dip card formats for detecting fentanyl at 1ng sensitivity. The test is designed for harm reduction and home use, and is authorized for Canadian distribution. Available variants: SAFElife™ Fentanyl Urine Home Test.
Co-Innovation Biotech Co., Ltd · China
A rapid diagnostic test strip for detecting fentanyl in powder samples. Provides quick identification of this potent opioid for substance analysis and safety purposes.
nal von minden GmbH · Germany
Rapid immunoassay test for qualitative detection of fentanyl in urine or other biological samples. Designed for point-of-care screening in clinical, occupational health, and substance monitoring settings. Delivers results in minutes using a simple test strip format requiring minimal sample volume.
Hangzhou Pefectech Biotechnology Co., Ltd. · China
A rapid diagnostic test device for detecting fentanyl in urine samples. This high-sensitivity test is part of the comprehensive drug of abuse detection portfolio for medical monitoring and law enforcement applications.
Boston Easy Biotech Inc. · United States
FDA-cleared rapid dual immunoassay test for simultaneous detection of fentanyl and norfentanyl in biological specimens. Designed for drug screening in clinical and point-of-care settings, enabling fast, reliable results to support substance use monitoring and pain management protocols.
ASC LLC · United States
Rapid immunoassay test strip for simultaneous detection of fentanyl and xylazine in urine specimens. Designed for point-of-care drug screening in occupational health, clinical, and harm reduction settings. Results obtained within minutes with visual interpretation.
Famwell · United States
FDA-cleared rapid test kit formulated for home-based detection of fentanyl and its primary metabolite norfentanyl in urine specimens. Designed for accessible substance screening with 5-minute result times.
Boston Easy Biotech Inc. · United States
FDA-cleared rapid immunoassay test using colloidal gold technology for fentanyl and norfentanyl detection. Provides reliable results in clinical and point-of-care settings. Designed for quick turnaround in opioid screening applications.
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