Wondfo One Step hCG Pregnancy Urine Test Cassette | CLIA Waived

SKU: H1-C-25BX-CLIA

Test Format: Cassette

Sample Type: Urine

Sensitivity: 20 mIU/mL

Quantity: 25 tests/box*

Classification: CLIA Waived; FDA 510(k) Cleared; Health Canada Class II

The Wondfo One Step hCG Pregnancy Test Cassette is a rapid test for the qualitative detection of human chorionic gonadotropin (hCG) in urine. Designed for professional pregnancy screening, the cassette provides easy-to-read visual results in approximately 3–5 minutes.

Each individually packaged cassette includes a specimen dropper for controlled urine application and a built-in procedural control. The test offers >99% specificity and is designed for clinics, healthcare providers, testing facilities, and other professional screening environments.

Key Features & Benefits

       ✔ CLIA Waived – Designed for qualifying waived testing environments

       ✔ FDA 510(k) Cleared – Cleared for its intended use

       ✔ 20 mIU/mL Sensitivity – Supports early hCG detection

       ✔ >99% Specificity – Reliable visual screening when used as directed

       ✔ Rapid Results – Results in approximately 3–5 minutes

·       ✔ Simple Application – Uses a controlled 3-drop urine application

       ✔ Complete Cassette Format – Includes specimen dropper and built-in procedural control

       ✔ Individually Packaged – Sealed in a moisture-resistant pouch with desiccant

       ✔ Professional Design – Includes a patient ID area for recording test information

       ✔ Room-Temperature Storage – Convenient storage for clinical settings

Product Specifications