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 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. One Step hCG Pregnancy Test Strip FDA Cleared CLIA Waived & OTC 50/BX is an accurate and economical choice for medical facilities and clinics requiring rapid pregnancy tests.

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 a 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