Biokit S.A.

Country not established FDA

Devices: 0
Registrations: FDA
FDA recalls: 11 ongoing

No devices from this company are in the catalogue yet.

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA establishment, FDA recalls

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 0
2021 0
2022 1
2023 0
2024 0
2025 0
2026 0

2022
- 28 Sep 2022 Z-1021-2023 Class II Ongoing HSV-2 rapid test may report false positive results. Distribution: US Nationwide distribution in the states of NY, CA, IN, NC, VA. Submission number: K983886

FDA establishments1

Registered with the FDA under this company group, matched by name.

Biokit, S.A. LLISSA D AMUNT Barcelona · ES FEI 3002806557