FDA-Device2025-12-10Class II
2 in 1 Trichomonas / Gardnerella Test
GET TESTED INTERNATIONAL AB
Hazard
Distribution without premarket approval/clearance.
Sold states
US Nationwide distribution.
Affected count
754 units
Manufactured in
59334 Vastervik, Lysingsvagen 18, Vastervik, Sweden
Products
2 in 1 Trichomonas / Gardnerella Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0816-2026Don't want to check this manually?
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