Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007420875

FEI Number

3007420875

Entity Name

GeneOhm Sciences Canada, ULC.

City/State/Country

Quebec, CA

Establishment Address

2555 Boul. du Parc-Technologique, Quebec G1P 4S5, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Becton Dickinson and Company (Owner Number: 9922032)

Owner / Operator Contact Address

One Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111860

PMA Number

N/A

All Registered Proprietary Names

BD Swab Diluent for BD ProbeTec Qx Amplified DNA Assays Urine Preservative Transport for BD ProbeTec Qx Amplified DNA Assays Control Set for the BD ProbeTec (CT/GC) BD Vaginal Specimen Transport for BD ProbeTec Qx Amplified DNA Assays BD Viper Neutralization Pouch BD Viper Extraction Reagent and Lysis Trough BD FOX Extraction Tubes BD ProbeTec Qx Collection Kit for Endocervical or Lesion Specimens Male Urethral Collection Kit for BD ProbeTec (CT/GC) Qx Amplified DNA Assays BD MAX Vaginal Panel BD BBL Thioglycollate Medium without Indicator BD Difco Supplement C BD Difco Nitrate Broth BD BBL Casman Agar Base BD BBL SIM Medium BD BBL CLED Agar BD BBL Phytone Yeast Extract Agar BD BBL Trichosel Broth, Modified BD BBL Enterococcosel Agar BD Difco Tryptic Soy Broth without Dextrose BD BBL Hemoglobin Solution 2% BD Difco Egg Yolk Enrichment 50% BD BBL Middlebrook ADC Enrichment BD Difco Fluid Thioglycollate Medium with Beef Extract BD Difco CHROMagar Salmonella BD Difco MacConkey Sorbitol Agar BD Difco Urea Broth BD Difco Lactose BD Difco MacConkey Agar without Salt BD BBL Cary-Blair Transport Medium BD Difco Antimicrobic Vial K BD BBL Kligler Iron Agar BD Difco Decarboxylase Medium Base BD BBL Eosin Methylene Blue Agar, Levine BD Difco Pseudomonas Isolation Agar BD Difco Heart Infusion Agar BD Difco Yersinia Selective Agar Base BD BBL MacConkey Agar without Crystal Violet BD Difco Oxgall (Dehydrated Fresh Bile) BD Difco Cetrimide Agar Base BD Difco Dextrose BD Difco Soluble Starch BD BBL Fluid Thioglycollate Medium BD Difco Phenol Red Mannitol Agar BD BBL Moeller Decarboxylase Broth Base BD BBL Transport Medium BD BBL Urea Agar Base BD Difco Saccharose BD Difco Koser Citrate Medium BD Difco MIL Medium BD Difco Hektoen Enteric Agar BD Difco SS Agar BD Difco Beef Heart BD Difco OF Basal Medium BD ZeroFoam BD Horizon Brilliant Stain Buffer BD Detergent Solution Concentrate BD Extended Flow Cell Clean Solution BD Alcohol Blend Rinse BD MAX DNA MMK (SPC) BD FACSFlow Sheath Fluid BD BBL Schaedler Agar BD FACSRinse Solution BD Sheath Additive BD Disinfectant-nCL BD BBL Bovine Albumin (Fraction V) BD Difco Agar BD Difco Brain Heart Infusion Agar BD Stabilizing Fixative BD BBL Saline, Normal BD BBL Mannitol Salt Agar BD Difco Tryptic Soy Blood Agar Base No. 2 BD Difco Yeast Carbon Base BD Difco Cooked Meat Medium BD Difco MacConkey Broth BD Difco Candida BCG Agar Base BD Difco Pseudomonas Agar F BD BBL Phosphate Buffer, pH 7.2 BD BBL V-C-N Inhibitor BD BBL Mycosel Agar BD Difco MacConkey Agar Base BD FACS Sheath Solution with Surfactant BD Difco Lysine Iron Agar BD Difco Leptospira Medium Base EMJH BD BBL Phenol Red Broth Base BD Difco Potato Dextrose Broth BD BBL V-C-N-T Inhibitor BD Difco Sabouraud Brain Heart Infusion Agar Base BD BBL Brucella Broth BD Difco Veal Infusion Broth BD BBL Brucella Agar BD Difco Salicin BD Difco D-Sorbitol BD Difco Todd Hewitt Broth BD Difco Azide Blood Agar Base BD Difco Tinsdale Agar Base BD Difco Potato Dextrose Agar BD BBL Brain Heart Infusion BD Difco Columbia Blood Agar Base BD Difco SBG Sulfa Enrichment BD Difco Fraser Broth Supplement BD Difco Phenylalanine Agar BD Difco Brewer Anaerobic Agar BD Difco Columbia Broth BD BBL Inhibitory Mold Agar BD Difco Antimicrobic Vial A BD Difco Lysine Decarboxylase Broth BD BBL Trypticase Soy Broth BD BBL LBS Agar BD Difco Agar, Technical BD Difco Nutrient Broth BD BBL Seven H11 Agar Base BD Difco Nutrient Agar 1.5% BD BBL Columbia Agar Base BD BBL Dermatophyte Test Medium Base BD Difco D-Galactose BD Difco Nutrient Gelatin BD BBL Trypticase Soy Agar, Modified (TSA II) BD Difco Desoxycholate Agar BD BBL Brain Heart Infusion Broth, Modified BD Difco PPLO Agar BD BBL FTA Hemagglutination Buffer BD Difco Brilliant Green Agar BD Difco Middlebrook 7H9 Broth BD FACSClean Solution BD Difco Eugon Agar BD Difco MIO Medium BD Difco Tween 80 BD BBL Phenol Red Mannitol Broth BD Difco Novobiocin Antimicrobic Supplement BD Difco Asparagine BD BBL Select Agar BD Difco FA Buffer, Dried BD Difco Nutrient Agar BD BBL Enterococcosel Broth BD BBL Indole Nitrite Medium BD BBL Bile Esculin Agar BD BBL Blood Agar Base Infusion Agar BD Difco Agar, Noble BD BBL Corn Meal Agar BD BBL MR-VP Broth 659611_BD Horizon Brilliant Stain Buffer BD BBL Phenol Red Lactose Broth BD Difco Thioglycollate Medium without Indicator BD Difco ISP Medium 4 BD Difco Lowenstein Medium Base BD Difco Selenite Broth BD Difco Bile Salts No. 3 BD Difco Tryptic Soy Agar BD BBL MacConkey Agar BD BBL BiGGY Agar BD Difco Bordet Gengou Agar Base BD Difco Eugon Broth BD Difco Starch Agar BD BBL Trypticase Soy Broth, Sterile BD BBL TSN Agar BD Difco Tryptose Phosphate Broth BD BBL Simmons Citrate Agar BD BBL Motility Test Medium BD FACS Shutdown Solution BD Difco Sabouraud Dextrose Agar BD Difco Sabouraud Agar, Modified BD Difco Tryptose Broth BD Difco Cystine Tryptic Agar BD Difco Brain Heart Infusion BD Difco Gelatin BD BBL Vitamin K1 - Hemin Solution BD Difco D-Mannitol BD MAX DNA MMK BD BBL Egg Yolk Tellurite Enrichment BD Difco Mitis Salivarius Agar BD BBL MycoPrep Kit BD Difco PPLO Broth BD Difco Liver Infusion Broth BD Difco Glycerol BD Difco NIH Thioglycollate Broth BD BBL Phenylethyl Alcohol Agar BD Difco ISP Medium 2 BD Difco Fluid Thioglycollate Medium BD Difco DNase Test Agar BD Difco Tinsdale Enrichment Desiccated BD Difco Anaerobic Agar BD BBL Thioglycollate Medium, Brewer Modified BD MAX TNA MMK(SPC) BD Difco Sodium Desoxycholate BD BBL Trypticase Soy Agar BD Difco Purple Agar Base BD BBL Brain Heart Infusion Agar BD Difco Motility GI Medium BD Difco Tryptose Agar BD BBL GN Broth BD Difco GN Broth, Hajna BD BBL Mycophil Agar with Low pH BD Difco Columbia Agar Base II BD BBL Salmonella Shigella Agar BD Difco Purple Broth Base BD Difco Malonate Broth BD BBL Middlebrook OADC Enrichment BD Difco Leptospira Enrichment EMJH BD Difco Antimicrobic Vial P BD BBL Litmus Milk BD Difco GC Medium Base BD Difco EY Tellurite Enrichment BD Difco Triple Sugar Iron Agar BD Difco Pseudomonas Agar P BD BBL Phenol Red Dextrose Broth BD Difco Yersinia Antimicrobic Supplement CN BD Difco MacConkey Agar BD BBL IsoVitaleX Enrichment BD Difco Desoxycholate Lactose Agar BD Difco TCBS Agar BD Difco Brain Heart Infusion, Porcine BD BBL Mycoplasma Broth Base BD Rhamnose BD Difco Supplement B with Reconstituting Fluid BD Difco Dubos Broth Base BD BBL Agar, Grade A BD Difco Liver Veal Agar BD BBL Hemoglobin, Bovine, Freeze-Dried BD BBL Eosin Methylene Blue Agar, Modified BD BBL Columbia CNA Agar BD Difco Supplement VX with Reconstituting Fluid BD BBL CTA Medium BD BBL MacConkey II Agar BD BBL Mycoplasma Agar Base BD BBL BCYE Agar Base BD Difco Columbia Blood Agar Base EH BD BBL Spirolate Broth BD Difco XLD Agar BD Difco Sabouraud Dextrose Broth BD Difco Legionella Agar Enrichment BD Difco Heart Infusion Broth BD Difco Tryptic Soy Broth BD Difco Skim Milk BD Difco Maltose BD Difco Selenite Cystine Broth BD Difco Mycoplasma Supplement BD Difco Tryptose Blood Agar Base BD Difco Raffinose BD Difco Charcoal Agar BD Difco Agar, Granulated BD COR MX Instrument BD CTGCTV2 BD COR PX Instrument BD MAX Cdiff BD MAX System BD MAX Extended Enteric Bacterial Panel BD MAX System BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel Diluent for BD COR System Bacterial Panel plus for BD COR System, and Enteric BD MAX Enteric Parasite Panel BD MAX System BD Pre-warm Heater BD MAX ExK TNA-3 BD MAX ExK TNA-2 BD MAX ExK DNA-3 BD MAX ExK DNA-2 BD MAX System BD MAX ExK DNA-1 BD Respiratory Viral Panel for BD MAX System BD Respiratory Viral Panel-SCV2 for BD MAX System BD MAX Enteric Viral Panel BD MAX System BD MAX CPO BD MAX System BD SARS-CoV-2 Reagents for BD MAX System BD MAX StaphSR BD MAX System BD MAX Vaginal Panel BD MAX System BD Molecular Swab Collection Kit BD Molecular Swab Collection Kit BD Molecular LBC Sample Buffer Tubes BD Molecular Swab Sample Buffer Tubes BD Molecular Urine Transport Kit BD MAX CTGCTV2 BD MAX System BD MAX System BD MAX Vaginal Panel BD MAX Enteric Parasite Panel BD Pre-Warm Heater BD MAX System BD Vaginal Panel BD COR MX Instrument BD COR PX Instrument BD CTGCTV2 BD MAX MRSA XT BD MAX System BD PCR Cartridge BD MAX GBS Assay BD MAX System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2009-01-27
PQA	Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	Microbiology	Class 2	866.3975	2023-06-06
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2007-04-06
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2022-05-19
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2022-05-19
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2022-05-19
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2022-05-19
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2013-04-08
OZN	C. Difficile Toxin Gene Amplification Assay	Microbiology	Class 2	866.3130	2013-04-08
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2017-06-07
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2025-12-03
PCI	Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2025-12-03
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2025-12-03
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2023-01-19
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2023-01-19
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2004-12-23
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2023-08-01
QQX	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	Microbiology	Class 2	866.3981	2023-08-01
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2023-01-12
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2023-01-12
POC	System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen	Microbiology	Class 2	866.1640	2019-10-31
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2019-10-31
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2025-12-01
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Microbiology	Class 2	866.1640	2013-11-29
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2013-11-29
PQA	Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	Microbiology	Class 2	866.3975	2023-06-06
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2021-08-16
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2021-08-16
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2021-08-16
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2016-11-04
PQA	Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	Microbiology	Class 2	866.3975	2016-11-04
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2016-11-04
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2016-11-04
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2015-08-26
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2015-08-26
PQA	Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	Microbiology	Class 2	866.3975	2023-04-11
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2023-04-11
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2023-04-11
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2023-04-11
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2025-08-12
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2025-08-12
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2025-08-12
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2025-08-12
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2025-08-12
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Microbiology	Class 2	866.1640	2014-01-14
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2014-01-14
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2012-02-22
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	Microbiology	Class 1	866.3740	2012-02-22

Official Correspondent

No official correspondent registered.

US Agent Details

Jeffrey Zinza Business: BECTON DICKINSON AND COMPANY Email: jeffrey.zinza@bd.com Phone: (858) 2093953

Related Public Records

Same Entity

Becton Dickinson and Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680577	BECTON DICKINSON GMBH	HEIDELBERG Baden-Wurttemberg, DE
3003916417	BECTON DICKINSON IND. CIRURGICAS LTDA.	CURITIBA Parana, BR
3036495171	BD Biosciences San Diego	San Diego, CA, US
3015292643	BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES	San Diego, CA, US
3010141591	BD Kiestra B.V.	Drachten Fryslan, NL

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

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1119779	BECTON, DICKINSON & CO.	SPARKS, MD, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007420875. Last updated year: 2026. Please use registration number 3007420875 when referencing this establishment in official correspondence.