# Geneohm Sciences Canada, Inc. (Bd Diagnostics)

- Location (FDA's records): Quebec, CA
- FDA decisions: 4 (2013–2019): 3 510(k) clearances and 1 De Novo grant
- Product codes: PQA (2), NQX (1), OZN (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 13 (1 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bd Diagnostics (Geneohm Sciences Canada, Inc): 2 (https://510kreport.com/company/bd-diagnostics-geneohm-sciences-canada)
- Bd Diagnostics (Geneohm Sciences, Inc.): 1 (https://510kreport.com/company/bd-diagnostics-geneohm-sciences)

## Firms that cite its devices most
- Hologic, Inc.: 2 (https://510kreport.com/company/hologic)
- Geneohm Sciences Canada, Inc. (Bd Life Sciences): 2 (https://510kreport.com/company/geneohm-sciences-canada-bd-life-sciences)
- Roche Molecular Systems, Inc.: 2 (https://510kreport.com/company/roche-molecular-systems)
- Becton, Dickinson & CO: 2 (https://510kreport.com/company/becton-dickinson)
- Cepheid: 1 (https://510kreport.com/company/cepheid)
- Genepoc, Inc.: 1 (https://510kreport.com/company/genepoc)
- Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC: 1 (https://510kreport.com/company/focus-diagnostics-dba-diasorin-molecular)
- Primeradx: 1 (https://510kreport.com/company/primeradx)

## Its most-cited devices
- DEN160001: BD MAX Vaginal Panel, BD MAX Instrument (2016), cited by 5
- K191957: BD MAX Vaginal Panel (2019), cited by 4
- K130470: BD Max Cdiff Assay, BD Max Instrument (2013), cited by 4

## Recent decisions
- K191957: BD MAX Vaginal Panel (Oct 21, 2019)
- DEN160001: BD MAX Vaginal Panel, BD MAX Instrument (Oct 28, 2016)
- K132822: BD Max Staphsr Assay, Instrument (Nov 26, 2013)
- K130470: BD Max Cdiff Assay, BD Max Instrument (Apr 2, 2013)

Source page: https://510kreport.com/company/geneohm-sciences-canada-bd-diagnostics