510(k) Report

FDA applicant

Geneohm Sciences Canada, Inc. (Bd Diagnostics)

Quebec, CA4 decisions2013–20194 recalls

FDA records 4 decisions for Geneohm Sciences Canada, Inc. (Bd Diagnostics) (Quebec, CA) from 2013 to 2019: 3 510(k) clearances and 1 De Novo grant. Most are in product codes PQA (Vaginitis And Bacterial Vaginosis Nucleic Acid…) and NQX (System, Nucleic Acid Amplification Test, Dna…). Its devices cite 4 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Geneohm Sciences Canada, Inc. (Bd Diagnostics)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2013: 22016: 12019: 1
2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2025

2019: 22024: 12025: 1
2013high 2 (2019) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Geneohm Sciences Canada, Inc. (Bd Diagnostics) by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Geneohm Sciences Canada, Inc. (Bd…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection System2decisions
  • NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus…1decision
  • OZNC. Difficile Toxin Gene Amplification Assay1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN160001BD MAX Vaginal Panel, BD MAX InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 20165cite it
  • K191957BD MAX Vaginal PanelGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 20194cite it
  • K130470BD Max Cdiff Assay, BD Max InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 20134cite it

What has FDA decided for it lately?

  • K191957BD MAX Vaginal PanelGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2019
  • DEN160001BD MAX Vaginal Panel, BD MAX InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2016
  • K132822BD Max Staphsr Assay, InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 20132 recalls
  • K130470BD Max Cdiff Assay, BD Max InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 20132 recalls

All 4 as Geneohm Sciences Canada, Inc. (Bd Diagnostics) →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K111860BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX…Sep 23, 2025Class II
  • K120138BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916Oct 31, 2024Class II
  • K132822Kit BD Max StaphSR; Catalog # 443419Jul 17, 2019Class II
  • K132822Kit BD Max StaphSR; Catalog # 443418Jul 17, 2019Class II

Other applicant names beginning “Geneohm”

FDA records each applicant name separately; these may or may not be the same firm.

Geneohm Sciences Canada, Inc. 2Geneohm Sciences Canada, Inc. (Bd Life Sciences) 1