Excel One Step Urine HCG Pregnancy Dipstick Test

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K970424 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Onestep Urine/Serum Hcg Module Pregnancy Test Kit

  Class II

  FDA 510(k) K955707 Active Cleared 2 May 1996

• Ez Sure (Excel) Urine Midstream Pregnancy Home Test

  Class II

  FDA 510(k) K971286 Active Cleared 8 May 1997

• Ez Sure Onestep Early Pregnancy Test

  Class II

  FDA 510(k) K962580 Active Cleared 29 Aug 1996

• Ez Sure Urine Dipstick Pregnancy Home Test

  Class II

  FDA 510(k) K970425 Active Cleared 6 Mar 1997

• Ez Sure One Step Ovulation Predictor Home Test Kit

  Class I

  FDA 510(k) K970467 Active Cleared 18 Mar 1997

• Excel Onestep Urine Hcg Module Pregnancy Test

  Class II

  FDA 510(k) K963231 Active Cleared 4 Dec 1996

See all devices from Excel Scientific, Inc. →

• What is the Excel One Step Urine HCG Pregnancy Dipstick Test used for?

  This test is a solid phase chromatographic immunoassay designed for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. It is intended for professional use to determine pregnancy status through visual results.

• How is the Excel One Step Urine HCG Pregnancy Dipstick Test supplied?

  The test is supplied in a dipstick format and is designed for single-use only. Each test is individually packaged and intended for one-time use to ensure accurate results and prevent cross-contamination.

• What is the regulatory status of this pregnancy test?

  The Excel One Step Urine HCG Pregnancy Dipstick Test is a Class II medical device cleared by the FDA under 510(k) K970424. It is regulated under product code JHI and regulation number 862.1155, with multiple registration numbers including 3013332582 and 3006198300.

• Is this pregnancy test reusable or single-use?

  This test is strictly for single-use only. After use, the dipstick should be discarded according to medical waste disposal guidelines. Reusing the test could lead to inaccurate results and potential contamination.