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.

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