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
- [email protected]
- Phone
- 858 2093953
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dna-Reagents, Neisseria | LSL | Class 2 | Microbiology | No | 2009-01-27 |
| Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | PQA | Class 2 | Microbiology | No | 2023-06-06 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2007-04-06 |
| Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | QEP | Class 2 | Microbiology | No | 2022-05-19 |
| Trichomonas Vaginalis Nucleic Acid Amplification Test System | OUY | Class 2 | Immunology | No | 2022-05-19 |
| Dna Probe, Nucleic Acid Amplification, Chlamydia | MKZ | Class 1 | Microbiology | No | 2022-05-19 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2013-04-08 |
| C. Difficile Toxin Gene Amplification Assay | OZN | Class 2 | Microbiology | No | 2013-04-08 |
| Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | PCH | Class 2 | Microbiology | No | 2017-06-07 |
| Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System | PCI | Class 2 | Microbiology | No | 2025-12-03 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2004-12-23 |
| Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | QOF | Class 2 | Microbiology | No | 2023-08-01 |
| Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | QQX | Class 2 | Microbiology | No | 2023-08-01 |
| System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen | POC | Class 2 | Microbiology | No | 2019-10-31 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2025-12-01 |
| System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | NQX | Class 2 | Microbiology | No | 2013-11-29 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2016-11-04 |
| Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | NJR | Class 1 | Microbiology | No | 2012-02-22 |
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