BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    BTNX Inc.

    Reg #: 3003917514 · FEI: 3003917514 · Expires 2026
    View on FDA
    Products
    77
    Proprietary Names
    108
    Establishment Types
    4
    Classifications
    77

    Registration Details

    Registration Name
    BTNX Inc.
    Registration Number
    3003917514
    FEI Number
    3003917514
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    722 Rosebank Road
    City
    Pickering Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K093143

    Owner / Operator

    Firm Name
    BTNX Inc.
    Operator Number
    9058575
    Address
    722 Rosebank Road
    City
    PICKERING
    State
    Ontario
    Postal Code
    L1W 4B2
    Country
    CA
    Correspondent
    Iqbal Sunderani

    US Agent

    Business Name
    Phil Triolo and Associates LC
    Contact Name
    Ryan O'callaghan
    Address
    1357 S 900 E
    City
    Salt Lake City
    State
    UT
    ZIP
    84105
    Country
    US
    Email
    [email protected]
    Phone
    801 5732651

    Products

    Device Name Product Code
    Devices, Breath Trapping, Alcohol DJZ
    Test, Propoxyphene, Over The Counter QBF
    Test, Barbiturate, Over The Counter PTH
    Test, Morphine, Over The Counter NGI
    Test, Cannabinoid, Over The Counter NFW
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Methadone, Over The Counter PTG
    Test, Amphetamine, Over The Counter NFT
    Test, Methamphetamine, Over The Counter NGG
    Test, Opiates, Over The Counter NGL
    Test, Benzodiazepine, Over The Counter NFV
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Glucose Oxidase, Glucose CGA
    System, Test, Blood Glucose, Over The Counter NBW
    Test, Amphetamine, Employment And Insurance Testing, Exempt PUX
    Reagent, Occult Blood KHE
    Visual, Pregnancy Hcg, Prescription Use JHI
    Test, Propoxyphene, Employment And Insurance Testing, Exempt PVI
    Reagent, Coronavirus Serological QKO
    Test, Benzodiazepine, Employment And Insurance Testing, Exempt PUZ
    Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt PVA
    Test, Barbiturate, Employment And Insurance Testing, Exempt PUY
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Refractometer For Clinical Use JRE
    Automated Urinalysis System KQO
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Test, Nitrite, Urinary, Non-Quantitative, Over The Counter NGJ
    Test, Urine Leukocyte LJX
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA
    Blood, Occult, Colorimetric, In Urine JIO
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Gas Chromatography, Methamphetamine LAF
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Barbiturate DIS
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Propoxyphene JXN
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Phencyclidine LCM
    Radioimmunoassay, Luteinizing Hormone CEP
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Thin Layer Chromatography, Methamphetamine DJC
    Thin Layer Chromatography, Morphine DNK
    Antigens, All Groups, Streptococcus Spp. GTY
    Test, Methamphetamine, Employment And Insurance Testing, Exempt PVD
    Test, Opiates, Employment And Insurance Testing, Exempt PVH
    Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus GQG
    Multi-Analyte Respiratory Virus Antigen Detection Test SCA
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Assay, Glycosylated Hemoglobin LCP
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Enzyme Linked Immunoabsorbent Assay, Rotavirus LIQ
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Test, Methadone, Employment And Insurance Testing, Exempt PVE
    Enzymatic Method, Creatinine JFY
    Urinalysis Controls (Assayed And Unassayed) JJW
    Test, Cannabinoid, Employment And Insurance Testing, Exempt PVJ
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Enzyme Immunoassay, Nicotine And Nicotine Metabolites MKU
    Container, Specimen, Sterile FMH
    Antigens, Cf (Including Cf Control), Adenovirus 1-33 GOD
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
    System, Test, Infectious Mononucleosis KTN
    Accessory, Surgical Apparel LYU
    Electrolyte Controls (Assayed And Unassayed) JJR
    Test System, Nicotine, Cotinine, Metabolites MRS
    Helicobacter Pylori LYR

    Proprietary Names

    Rapid Response Alcohol Breath Detector Rapid Response Multi-Drug Screen Cup Rapid Response Blood Glucose Monitoring System Rapid Response Drug Screening Saliva Test Rapid Response Single Drug Saliva Test Strip Rapid Response Multi-Drug Test Panel (Urine) Rapid Response Multi-Drug Test Cup (Urine) Rapid Response Drug Test Strip (Urine) Rapid Response Multi DOA Saliva Test Cup Rapid Response FIT - Fecal Immunochemical Test Rapid Response hCG Pregnancy Test (Cassette) Rapid Response COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) Rapid Response Drug Screen Panel BTNX Inc. Rapid Response U500 Urine Analyzer Rapid Response Digital Pregnancy Test Rapid Response Multi-Drug Urine Test DipCard Rapid Response Multi-Drug Urine Test Cup Rapid Response At-Home Fentanyl Test Cassette Rapid Response Fentanyl Test Cassette Rapid Response Fentanyl Test Cassette (Urine) Rapid Response Multi-Drug One Step Cup (Urine) Rapid Response One Step DOA Cup MOR 2000 (Urine) Rapid Response One Step DOA Cup MOR 300 (Urine) Rapid Response One Step DOA Test Cup (Urine) Rapid Response Single/Multi DOA Panel MOR 2000 (Urine) Rapid Response Single/Multi DOA Panel MOR 300 (Urine) Rapid Response Multi-Drug Test Cup Rapid Response LH Ovulation Test Rapid Response U120 Urine Analyzer BTNX Inc. Rapid Response UTI Urinary Tract Infection Test Strip Rapid Response Drug Screening Strip - OTC (Urine) Rapid Response Drug Screening Panel w/wo Adulteration (Urine) Rapid Response Drug Screening Cup - OTC (Urine) Rapid Response Drug Screening Cup w/wo Adulteration (Urine) Rapid Response Drug Screening Panel - OTC (Urine) Rapid Response Drug Screening Strip w/wo Adulteration (urine) L-Cup Home Rapid Test (Urine) L-Cup Rapid Test w/Adulteration (Urine) Rapid Response Strep A Test Strips BTNX Inc. Rapid Response hCG Pregnancy Test Strip OTC (Urine) (Strip) Rapid Response 720+ Urine Analyzer Rapid Response RSV Test Cassette BTNX Inc. Rapid Response Gluco-MD Blood Glucose Monitoring System BTNX Inc. Rapid Response hCG Pregnancy Test Strip (Urine) (Strip) Rapid Response Influenza AB + COVID-19 Antigen Detection Test (Anterior Nasal Swab) RAPID RESPONSE U120S URINE ANALYZER BTNX Inc. Rapid Response A1c System Rapid Response RSV Test Rapid Response Rotavirus Test Cassettes (Direct Ag/Visual) Rapid Response Drug Screen Cup Rapid Response Pregnancy Test 20mIU Rapid Response™ Safety Lancet Rapid Response Thyroid Stimulating Hormone (TSH) Test Cassette (Whole Blood) Rapid Response Strep A Test Rapid Response OTC Ovulation Test Rapid Response Microalbumin Creatinine Strips Rapid Response Strep A Rapid Test Strip BTNX Inc. Rapid Response Drugs of Abuse Test Cup BTNX Inc. Rapid Response Drugs of Abuse Test Panel BTNX Inc. Rapid Response Drugs of Abuse Test (Urine) Rapid Response Multi-Drug Test Panel Rapid Response Single-Drug Test Panel Rapid Response Single-Drug Test Strip Rapid Response Multi-Drug Integrated Split Spec. Cup Rapid Response Multi-Drug One-Step Cup Liquid Urine Control Teco Diagnostics Microalbumin 2-1 Combo Strip Rapid Response Microalbumin Creatinine Test Strip Rapid Response Influenza B Test Cassette Rapid Response Immunological Fecal Occult Blood Test (IFOBT) Rapid Response Fecal Immunochemical Test (FIT) BTNX Inc. Rapid Response LH Ovulation Test Cassette (Urine) Rapid Response Saliva Drug Test (COT) Rapid Response Saliva Drug Test (COT/THC) Plastic Collection Cup Rapid Response Pregnancy Combo Test Strip Rapid Response Pregnancy Test Strip Rapid Response Pregnancy Test Cassette Rapid Response Pregnancy Combo Cassette Rapid Response Influenza A Test Cassette Rapid Response Drug Monitoring Panel Rapid Response Home Drug Monitoring Panel Rapid Response Urinalysis Reagent Strips Rapid Response Adenovirus Test Cassette Rapid Response FSH Test Rapid Response™ Pregnancy Combo Test (Urine/Serum) Rapid Response Home Drug Monitoring Cup Rapid Response Drug Monitoring Cup Rapid Response Mononucleosis Rapid Test Device (wb/ser/plas) Rapid Response Mononucleosis Rapid Test Device (whole blood) Rapid Response Drug Test Panel Rapid Response Home Drug Test Cup Rapid Response Home Drug Test Panel Rapid Response Drug Test Cup BTNX Inc. Rapid Response Midstream Pregnancy Test OTC (Urine) (Midstream) Rapid Response Drugs of Abuse Multi-Drug Test Panel (Urine) Rapid Response Drugs of Abuse Test Strip (Urine) Rapid Response Disposable Mask BTNX, Inc. Rapid Response At-Home Pregnancy Test Rapid Response Drug Screening Panel Rapid Response Drug Screening Cup Rapid Response 10-SG Urinalysis Reagent Strip Rapid Response Cotinine Test Strip Rapid Response Single Drug Test Cassette Rapid Response Cotinine Test Cassette Rapid Response Cotinine Test Panel Rapid Response H. pylori Rapid Test Device (Serum/Plasma) Rapid Response H. pylori Rapid Test Device (Whole Blood)

    Establishment Types

    Foreign Private Label Distributor Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device