Intended Use
One Step Pregnancy Test is a device for rapid, visual and qualitative determination of human chorionic gonadotropin (HCG) in urine or serum to aid in early detection of pregnancy.
Test Item | Specimen | Sensitivity | Qualification | Format |
One Step Pregnancy Test | Urine | HCG 25mIU/mL | CE, MDSAP | Strip, Cassette, Midstream |
One Step Pregnancy Test | Urine | HCG 20mIU/mL | CE | Strip, Cassette, Midstream |
One Step Pregnancy Test | Urine | HCG 15mIU/mL | CE | Strip, Cassette, Midstream |
One Step Pregnancy Test | Urine | HCG 10mIU/mL | CE, MDSAP | Strip, Cassette, Midstream |
One Step Pregnancy Test | Urine/Serum | HCG 10mIU/mL |
| Strip, Cassette |
One Step Pregnancy Test | Urine/Serum | HCG 25mIU/mL |
| Strip, Cassette |
Pregnancy Urine Test (Dual Threshold) | Urine | HCG 25mIU/mL HCG 2000mIU/mL | CFDA | Cassette, Midstream |
Test Procedure & Inerpretation
