One Step hCG Pregnancy Test Strip CLIA Waived 50/Box

The hCG One Step Pregnancy Test (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

Human chorionic gonadotropin (hCG) is a hormone, produced by the developing placenta shortly after the conception and secreted into the urine and serum. hCG can be detected in both urine and serum as early as 7 to 10 days after conception. hCG levels continue to rise very rapidly, frequently 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.

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.

Features

• FDA 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
• Easy to operate and simple interpretation
• Room temperature storage or refrigerated (2-30⁰C)
• Internal control included

Additional

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

Specifications

• Cut-off(s): See ordering information
• Specimen: Urine
• Time to Results: 5 minutes
• Shelf Life: 24 months from the date of manufacture