FDA-Device2025-12-10Class II

Menopause (FSH) 2 Tests

GET TESTED INTERNATIONAL AB
Hazard

Distribution without premarket approval/clearance.

Sold states
US Nationwide distribution.
Affected count
184 units
Manufactured in
59334 Vastervik, Lysingsvagen 18, Vastervik, Sweden
Products
Menopause (FSH) 2 Tests

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0744-2026

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