FDA-Device2025-12-10Class IIMISBRANDING
Urinary Tract Infection Test
Hazard
Distribution without premarket approval/clearance.
Who it affects
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
40 units
Manufactured in
59334 Vastervik, Lysingsvagen 18, Vastervik, Sweden
Products
Urinary Tract Infection Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0754-2026Don't want to check this manually?
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