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Biokit, S.A.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories6
Latest FDA decision2025-02-12
TypeNumberDevice NameCodeDateActions
510(k) K243575 ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsMYF2025-02-12 View
510(k) K233606 ADVIA Centaur EBV-VCA IgMLSE2024-08-07 View
510(k) K233605 ADVIA Centaur EBV-EBNA IgGLLM2024-08-07 View
510(k) K213987 ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsMXJ2023-09-20 View
510(k) K214068 Quantia IgEDGC2023-02-21 View
510(k) K181333 ADVIA Centaur Herpes-1 IgGMXJ2018-08-23 View
510(k) K181334 ADVIA Centaur Herpes-2 IgGMYF2018-08-23 View
510(k) K152185 ARCHITECT SHBGCDZ2016-02-11 View
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