FDA-Device2025-12-10Class IIMISBRANDING
Peptic Ulcer Test (H, pylori)
Hazard
Distribution without premarket approval/clearance.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
12 units
Manufactured in
59334 Vastervik, Lysingsvagen 18, Vastervik, Sweden
Products
Peptic Ulcer Test (H, pylori)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0794-2026Want us to check the next one for you?
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