FDA-Device2025-12-10Class IIMISBRANDING

Allergy test Small

FALSE CLAIMSNationwide distributionMedical devices
Hazard

Distribution without premarket approval/clearance.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
19 units
Manufactured in
59334 Vastervik, Lysingsvagen 18, Vastervik, Sweden
Products
Allergy test Small

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0803-2026

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