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GeneOhm Sciences Canada, ULC.: FDA-registered device maker in Quebec, Canada, 22 510(k) clearances and 1 PMA approval

Name: GeneOhm Sciences Canada, ULC. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

GeneOhm Sciences Canada, ULC. is registered with the FDA (registration 3007420875) in Quebec, Canada. It lists 19 device types. The FDA files 22 510(k) clearances and 1 PMA approval under its listings, the newest dated October 31, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3007420875
Address: 2555 Boul. du Parc-Technologique, Quebec, Canada, G1P 4S5
Owner or operator: Becton Dickinson and Company (9922032)
Roles: Manufacturer
First device listed: December 23, 2004
Registered through: 2027
Brand names listed: 659611_BD Horizon Brilliant Stain Buffer, BD Alcohol Blend Rinse, BD BBL Agar, Grade A, BD BBL BCYE Agar Base, BD BBL BiGGY Agar, BD BBL Bile Esculin Agar, BD BBL Blood Agar Base Infusion Agar, BD BBL Bovine Albumin (Fraction V) and more

Devices it lists

Device	Product code	Class	Role	Source
C. Difficile Toxin Gene Amplification Assay	OZN	2	Manufacturer	accessdata.fda.gov
Clinical Sample Concentrator	JJH	1	Manufacturer	accessdata.fda.gov
Dna Probe, Nucleic Acid Amplification, Chlamydia	MKZ	1	Manufacturer	accessdata.fda.gov
Dna-Reagents, Neisseria	LSL	2	Manufacturer	accessdata.fda.gov
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System	PCI	2	Manufacturer	accessdata.fda.gov
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	PCH	2	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Instrumentation For Clinical Multiplex Test Systems	NSU	2	Manufacturer	accessdata.fda.gov
Kit, Dna Detection, Human Papillomavirus	MAQ	3	Manufacturer	accessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	QOF	2	Manufacturer	accessdata.fda.gov
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	NJR	1	Manufacturer	accessdata.fda.gov
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	QEP	2	Manufacturer	accessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic Acid	QJR	N	Manufacturer	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Manufacturer	accessdata.fda.gov
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	QQX	2	Manufacturer	accessdata.fda.gov
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen	POC	2	Manufacturer	accessdata.fda.gov
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	NQX	2	Manufacturer	accessdata.fda.gov
Trichomonas Vaginalis Nucleic Acid Amplification Test System	OUY	2	Manufacturer	accessdata.fda.gov
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	PQA	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 31, 2025	K250358	BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System	PCI	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
April 22, 2025	K243343	BD CTGCTV2	QEP	Substantially Equivalent	Bd Integrated Diagnostic Solutions/Becton,	accessdata.fda.gov
July 31, 2023	K230956	BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System	QOF	Substantially Equivalent	Bd Integrated Diagnostic Solutions /	accessdata.fda.gov
March 6, 2023	K223653	BD Vaginal Panel	PQA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
September 21, 2022	K220607	BD MAX Enteric Viral Panel	PCH	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
August 19, 2022	K220193	BD MAX Enteric Parasite Panel	PCH	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
July 28, 2022	K214122	BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel	PCI	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
May 10, 2022	K210585	BD CTGCTV2	QEP	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
October 18, 2021	K201017	BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit	PQA	Substantially Equivalent	Geneohm Sciences Canada, Inc. (Bd Life Sciences)	accessdata.fda.gov
October 21, 2019	K191957	BD MAX Vaginal Panel	PQA	Substantially Equivalent	Geneohm Sciences Canada, Inc. (Bd Diagnostics)	accessdata.fda.gov
August 29, 2019	K190613	BD MAX Check-Points CPO	POC	Substantially Equivalent	Check-Points Health B.V.	accessdata.fda.gov
January 8, 2019	K182692	BD MAX CTGCTV2, BD MAX System	OUY	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
November 29, 2018	K181427	BD MAX Enteric Viral Panel, BD MAX Instrument	PCH	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
May 2, 2017	K170308	BD MAX Extended Enteric Bacterial Panel, BD MAX System	PCH	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
October 28, 2016	DEN160001	BD MAX Vaginal Panel, BD MAX Instrument	PQA	Unknown	Geneohm Sciences Canada, Inc. (Bd Diagnostics)	accessdata.fda.gov
August 25, 2015	K143648	BD MAX Enteric Parasite Panel, BD MAX Instrument	PCH	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
May 6, 2014	K140111	BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT	PCI	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
December 20, 2013	K133605	BD MAX MRSA XT, BD MAX INSTRUMENT	NQX	Substantially Equivalent	Geneohm Sciences Canada, Inc.	accessdata.fda.gov
November 26, 2013	K132822	BD MAX STAPHSR ASSAY, INSTRUMENT	NQX	Substantially Equivalent	Geneohm Sciences Canada, Inc. (Bd Diagnostics)	accessdata.fda.gov
April 2, 2013	K130470	BD MAX CDIFF ASSAY, BD MAX INSTRUMENT	OZN	Substantially Equivalent	Geneohm Sciences Canada, Inc. (Bd Diagnostics)	accessdata.fda.gov
February 16, 2012	K111860	BD MAX GBS ASSAY, BD MAX INSTRUMENT	NJR	Substantially Equivalent	Becton, Dickinson & CO	accessdata.fda.gov
December 11, 2008	K081825	BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY	LSL	Substantially Equivalent	Becton, Dickinson & CO	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
February 12, 2018	P160037	BD ONCLARITY HPV ASSAY	MAQ	28	August 19, 2026	accessdata.fda.gov

Compare with other makers

Updated August 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.