HEALGEN SCIENTIFIC One Step hCG Test Cassette FDA Cleared-CLIA Waived & OTC (25/Box)
One Step hCG Test Cassette
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
Additional
- Private Label Options Available
- Strip and Midstream Formats Available
- 25/Box or 50/Box Options
Instructions
hCG Format Options
Product Name | Specimen | Format | Sensitivity | Catalog No. | Certifications |
hCG Pregnancy Rapid Test | Urine | Strip | 25 mIU/ml | GAHCG-101a | CE Marked FDA CLIA Waived |
hCG Pregnancy Rapid Test | Urine | Cassette | 25 mIU/ml | GAHCG-102a | CE Marked FDA CLIA Waived |
hCG Pregnancy Rapid Test | Urine | Midstream | 25 mIU/ml | GAHCG-103a | CE Marked FDA CLIA Waived |