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HealthyMe UTI Urinary Tract Infection Test Strips

Acon Laboratories, Inc. · Model 725125 · UDI-DI 00682607651252

JMTLJX
10
510(k) clearances
7
Adverse events
2
Recalls
78
Facilities

Description

Urinary Tract Infection home test with handle

Recalls

DateFirmReason
2023-05-22Universal 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
2023-05-22Universal 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.