One-Step hCG Rapid Diagnostic Midstream Pregnancy Test Urine, CLIA Waived, OTC, FDA Approved, 20 Tests/Box

The Pregnancy One Step Rapid Test (Midstream) is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy.

Features

• The test is for self testing
• FDA Cleared
• FDA CLIA Waived 510(k) # K123574
• OTC (Over-The-Counter) Non-prescription approved by the FDA 
• CE Marked
• Kit includes two pouches, each containing a midstream test device, Instruction for Use, and desiccant
• The desiccant is for storage purposes only and is not used in the test procedure
• A procedural control is included in the test
• Sensitivity 25 mIU / mL

Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced in pregnancy that is made by the developing embryo after conception and later by the syncytiotrophoblast. In normal pregnancy, hCG can be detected in urine as early as 1-2 weeks after conception. hCG levels continue to rise very rapidly, usually exceeding 100 mIU/mL by the first missed menstrual period, and peaking in the 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy. Early pregnancy testing, in general, is based on the detection or measurement of hCG. The Pregnancy One Step Rapid Test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine. Positive specimens react with the specific antibody-hCG-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. At the level of claimed sensitivity, the Pregnancy One Step Rapid Test shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.