Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SpainLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of WerfenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Biokit with 23 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Feb 12, 2025: ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 12, 2025 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsK243575 · MYF | 510(k) clearances |
| Aug 7, 2024 | ADVIA Centaur EBV-VCA IgMK233606 · LSE | 510(k) clearances |
| Aug 7, 2024 | ADVIA Centaur EBV-EBNA IgGK233605 · LLM | 510(k) clearances |
| Sep 20, 2023 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsK213987 · MXJ | 510(k) clearances |
| Feb 21, 2023 | Quantia IgEK214068 · DGC | 510(k) clearances |
| Sep 28, 2022 | biokitHSV-2 Rapid Test, REF: 300028001Class II · HSV-2 rapid test may report false positive results. | Device recalls |
| Aug 23, 2018 | ADVIA Centaur Herpes-2 IgGK181334 · MYF | 510(k) clearances |
| Aug 23, 2018 | ADVIA Centaur Herpes-1 IgGK181333 · MXJ | 510(k) clearances |
| Feb 11, 2016 | ARCHITECT SHBGK152185 · CDZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
