FDA Registration Active 🇨🇦 Canada

GeneOhm Sciences Canada, ULC.

Reg #: 3007420875 · FEI: 3007420875 · Expires 2026
Products
18
Proprietary Names
275
Establishment Types
1
Classifications
18

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Registration Details

Registration Name
GeneOhm Sciences Canada, ULC.
Registration Number
3007420875
FEI Number
3007420875
Status
Active
Expiry Year
2026
Initial Importer
No
Address
2555 Boul. du Parc-Technologique
City
Quebec
Country
CA

Regulatory Submissions

510(k) Number
K081825

Owner / Operator

Firm Name
Becton Dickinson and Company
Operator Number
9922032
Address
One Becton Drive
City
Franklin Lakes
State
NJ
Postal Code
07417
Country
US

US Agent

Business Name
BECTON DICKINSON AND COMPANY
Contact Name
Jeffrey Zinza
Address
7 Loveton Circle
City
Sparks
State
MD
ZIP
21152
Country
US
Phone
858 2093953

Products

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

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 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 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™ 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™ CPO BD SARS-CoV-2 Reagents for BD MAX System BD MAX™ StaphSR BD MAX™ Vaginal Panel 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 Pre-Warm Heater BD Vaginal Panel BD MAX™ MRSA XT BD PCR Cartridge BD MAX™ GBS Assay BD MAX™ Enteric Bacterial Panel

Establishment Types

Manufacture Medical Device