The Wondfo One Step hCG Pregnancy Test Strip (Product #W1-S) is a rapid, qualitative immunoassay for the early detection of human chorionic gonadotropin (hCG) in urine. Designed for professional and point-of-care environments, this CLIA Waived test provides highly reliable results with 99% accuracy in as little as 3 to 5 minutes. The simple “dip-and-read” strip format is a cost-effective alternative to laboratory testing, capable of detecting pregnancy as early as the first day of a missed period with a sensitivity of 25 mIU/mL. Sold in bags of 20 individually wrapped test strips.
Reproductive Health Test Kit hCG Pregnancy Test, CLIA Waived (20/Bag)
Product Specifications
| Specification | Details |
| Manufacturer / Brand | Wondfo USA Co Ltd |
| Manufacturer # / SKU | W1-S |
| McKesson Number | 1242160 |
| Product Type | Rapid Diagnostic Test Strip |
| Test Name | hCG Pregnancy Test |
| CLIA Classification | CLIA Waived / FDA Cleared / CE Marked |
| Sensitivity | 25 mIU/mL |
| Sample Type | Urine |
| Result Time | 3 – 5 Minutes |
| Strip Width | 3.5 mm |
| Packaging / Sold As | Bag of 20 (Individually Wrapped) |
| UNSPSC Code | 41116103 |
Key Features
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Early Detection: Highly sensitive 25 mIU/mL cutoff allows for the detection of pregnancy shortly after conception.
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Rapid Clinical Results: Eliminates the 24–48 hour wait for lab results by providing a visual, qualitative “Yes/No” result in 5 minutes.
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Easy “Dip” Procedure: Simple diagnostic workflow requires only immersing the strip into a urine specimen for 10 seconds.
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Professional Grade: Widely used in clinical environments and physician offices; also available in over-the-counter (OTC) formats.
⚠️ Handling: For in vitro diagnostic use only. Store at room temperature between 4°C and 30°C (39°F and 86°F). Do not use past the expiration date. Ensure the urine level does not exceed the “MAX” line on the strip during testing.





