Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Geneohm Sciences Canada with 6 510(k) clearances. The most recent is a 510(k) clearance dated Oct 18, 2021: BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit.
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.
| Date | Record | Source |
|---|---|---|
| Oct 18, 2021 | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitK201017 · PQA | 510(k) clearances |
| Oct 21, 2019 | BD MAX Vaginal PanelK191957 · PQA | 510(k) clearances |
| Oct 28, 2016 | BD MAX Vaginal Panel, BD MAX InstrumentDEN160001 · PQA | 510(k) clearances |
| Dec 20, 2013 | BD MAX MRSA XT, BD MAX INSTRUMENTK133605 · NQX | 510(k) clearances |
| Nov 26, 2013 | BD MAX STAPHSR ASSAY, INSTRUMENTK132822 · NQX | 510(k) clearances |
| Apr 2, 2013 | BD MAX CDIFF ASSAY, BD MAX INSTRUMENTK130470 · OZN | 510(k) clearances |
| Aug 30, 2006 | IDI-VANR ASSAYK061686 · NIJ | 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
