FDA-Device2025-12-10Class IIMISBRANDING

Food Intolerance Test Medium

FALSE CLAIMSNationwide distributionMedical devices
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Hazard

Distribution without premarket approval/clearance.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
16 units
Manufactured in
59334 Vastervik, Lysingsvagen 18, Vastervik, Sweden
Products
Food Intolerance Test Medium

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0807-2026

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