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Surearly™ Pregnancy Test Strip

Sugentech Inc._Osong Branch · Model HCGS003E · UDI-DI 08809408860597

LCX

510(k) clearances

236

Adverse events

Recalls

120

Facilities

Description

Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the strip is a sample pad for urine dipping, and the control and test regions are located in the middle of the strip. Users immerse the sample pad of the strip into the collected urine and see the test results from the colored lines appeared on the strip. The test results are interpreted by users according to the instructions for use.

Recalls

Date	Firm	Reason
2025-12-26	GOLD STAR DISTRIBUTION INC	Potential exposure of rodents and rodent activity in the distribution center.
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2023-10-04	Family Dollar Stores, Llc.	Products were stored outside of labeled temperature requirements.
2023-10-04	Family Dollar Stores, Llc.	Products were stored outside of labeled temperature requirements.
2023-10-04	Family Dollar Stores, Llc.	Products were stored outside of labeled temperature requirements.
2023-05-22	Universal Meditech Inc.	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri
2023-05-22	Universal Meditech Inc.	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri
2023-05-22	Universal Meditech Inc.	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri
2023-05-22	Universal Meditech Inc.	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri
2023-05-22	Universal Meditech Inc.	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.