One Step hCG Rapid Test Cassette FDA Cleared, CLIA Waived & OTC 25/Box

This rapid test cassette detects human chorionic gonadotropin (hCG), a hormone produced during pregnancy. hCG can typically be detected in urine 1–2 weeks after conception, with levels rising rapidly and often exceeding 100 mIU/mL by the time of the first missed period. One Step hCG Rapid Test Cassette FDA Cleared CLIA Waived & OTC 25/Box delivers reliable results in minutes, making it an ideal choice for professional clinical settings.

The One Step hCG Pregnancy Test uses monoclonal and polyclonal antibodies to accurately identify elevated hCG levels in urine. A visible colored line appears in the test region for positive results. The test demonstrates high specificity and does not cross-react with structurally related hormones, including hFSH, hLH, and hTSH, at high physiological levels.

Features

• CLIA Waived
• 510(k) # K123703
• CE Marked
• FDA Cleared
• OTC (Over-The-Counter) Non-prescription approved by the FDA 
• Test Results in 5 Minutes
• Cassette Format with Pipette
• 25 mIU/ml Sensitivity
• One Step Rapid Test (Cassette) is an in vitro diagnostic visual qualitative immunochromatographic assay
• Rapid test for the determination of human chorionic gonadotropin (hCG) in urine
• Reliable & Easy to Use

Additional

• Private Label Options Available
• Strip and Midstream Formats Available
• 25/Box or 50/Box Options

Instructions