BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ASSURE TECH LLC

    Reg #: 3030648160 · FEI: 3030648160 · Expires 2026
    View on FDA
    Products
    48
    Proprietary Names
    29
    Establishment Types
    2
    Classifications
    48

    Registration Details

    Registration Name
    ASSURE TECH LLC
    Registration Number
    3030648160
    FEI Number
    3030648160
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1521 Concord Pike Suite 201
    City
    Wilmington
    State
    DE
    ZIP
    19803
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181768

    Owner / Operator

    Firm Name
    Assure Tech LLC
    Operator Number
    10090182
    Address
    1521 Concord Pike Suite 201
    City
    Wilmington
    State
    DE
    Postal Code
    19803
    Country
    US
    Correspondent
    Allen Chen

    Products

    Device Name Product Code
    Test, Propoxyphene, Over The Counter QBF
    Test, Methadone, Over The Counter PTG
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Amphetamine, Over The Counter NFT
    Test, Methamphetamine, Over The Counter NGG
    Test, Benzodiazepine, Over The Counter NFV
    Test, Cannabinoid, Over The Counter NFW
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Opiates, Over The Counter NGL
    Test, Barbiturate, Over The Counter PTH
    Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt PVA
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Visual, Pregnancy Hcg, Prescription Use JHI
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Test, Methamphetamine, Employment And Insurance Testing, Exempt PVD
    Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA
    Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt PVK
    Over-The-Counter Covid-19 Antigen Test QYT
    Test, Morphine, Employment And Insurance Testing, Exempt PVG
    Test, Opiates, Employment And Insurance Testing, Exempt PVH
    Test, Benzodiazepine, Employment And Insurance Testing, Exempt PUZ
    Enzyme Immunoassay, Barbiturate DIS
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Phencyclidine LCM
    Devices, Breath Trapping, Alcohol DJZ
    Test, Barbiturate, Employment And Insurance Testing, Exempt PUY
    Test, Methaqualone, Employment And Insurance Testing, Exempt PVF
    Test, Urine Leukocyte LJX
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Test, Amphetamine, Employment And Insurance Testing, Exempt PUX
    Test System, Nicotine, Cotinine, Metabolites MRS
    Device, Fertility Diagnostic, Proceptive LHD
    Test, Methadone, Employment And Insurance Testing, Exempt PVE
    Test, Propoxyphene, Employment And Insurance Testing, Exempt PVI
    Enzyme Immunoassay, Propoxyphene JXN
    Enzyme Immunoassay, Benzodiazepine JXM
    Gas Chromatography, Methamphetamine LAF
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Acid, Uric, Uricase (Colorimetric) KNK

    Proprietary Names

    Rapid Diagnostic Tests Ketones Urinary Test FaStep Pregnancy Rapid Test Cassette Fastep HCG Rapid Test Cassette AssureTech Quick Cup Tests AssureTech Multi-drug Urine Test Cup AssureTech Multi-drug Urine Test Panel AssureTech Panel Dip Tests HealCare LH Ovulation Rapid Test OvaMate Fertility Predictor kit (With OvaMate APP) Vitamin C Urinary Test Fastep COVID-19 Antigen Pen Home Test Fastep COVID-19 Antigen Pen Test FaStepTM Fentanyl Rapid Test Device FaStepTM Rapid Fentanyl Urine Test HealCare HCG Pregnancy Rapid Test HealCare HCG Pregnancy Rapid Test Midstream Nitric Oxide Indicator Strip Nitrite Urinary Test OvaMate Menopause Predictor kit (With OvaMate APP) HealCare FSH Menopause Rapid Test Breath Alcohol Test Leukocytes Urinary Test PH Urinary Test FaStep Early Pregnancy Rapid Test Strip FaStep Early Pregnancy Rapid Test Cassette FaStep Early Pregnancy Rapid Test Midstream OvaMate Fertility Tracker Uric Acid Urinary Test

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility