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Surearly™ Digital Pregnancy Test

Sugentech Inc._Osong Branch · Model SU-DR02-CG · UDI-DI 08809408860191

LCX

510(k) clearances

236

Adverse events

Recalls

120

Facilities

Description

Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, combining with an absorbent tip covered by a plastic cap. The absorbent tip that protrudes from the end of the test reader absorbs and delivers urine to reagents on a RAPID type test strip which is located inside a plastic housing of the device. The test reader is automatically switched on, by removing the power film located at the grip. The absorbent tip is placed in urine stream directly or alternatively immersed into the collected urine. The test reader detects the colored lines and shows the digital test result on the display.

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.