BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BOSTON EASY BIOTECH INC

    Reg #: 3024753119 · FEI: 3024753119 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    20
    Establishment Types
    4
    Classifications
    25

    Registration Details

    Registration Name
    BOSTON EASY BIOTECH INC
    Registration Number
    3024753119
    FEI Number
    3024753119
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    200 Brickstone Square, Suite 104
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222305

    Owner / Operator

    Firm Name
    Boston Easy Biotech Inc
    Operator Number
    10086310
    Address
    200 Brickstone Square, Suite 104
    City
    Andover
    State
    MA
    Postal Code
    01810
    Country
    US
    Correspondent
    ZHI Chen

    Products

    Device Name Product Code
    Plasmodium Spp. Detection Reagents OAX
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Immunohistochemical Assay, Helicobacter Pylori OWF
    Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii LGD
    Reagent, Occult Blood KHE
    Analyzer, Chemistry, Micro, For Clinical Use JJF
    Test, Cannabinoid, Over The Counter NFW
    Test, Benzodiazepine, Over The Counter NFV
    Test, Amphetamine, Over The Counter NFT
    Test, Propoxyphene, Over The Counter QBF
    Test, Opiates, Over The Counter NGL
    Test, Barbiturate, Over The Counter PTH
    Enzyme Immunoassay, Opiates DJG
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Methadone, Over The Counter PTG
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Methamphetamine, Over The Counter NGG
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies NWY
    Dengue Virus Antigen Assay QCU
    Enzyme Immunoassay, Cannabinoids LDJ
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Helicobacter Pylori LYR
    Test, Morphine, Over The Counter NGI

    Proprietary Names

    BEB Plasmodium spp. Detection Test Famwell Digital Pregnancy Rapid Test BEB H. pylori Rapid Test BEB Toxo Igg Li BEB OCCULT BLOOD Test BEB Urine Drug Rapid Tests Influenza Combo Test BEB dengue igm and igg antibodies test BEB Fentanyl Rapid Tests Famwell Flu A/B Antigen Rapid Test BEB Dengue virus antigen Test BEB Multi-Drug Test Kit Famwell LH Ovulation Rapid Test Strip Famwell LH Rapid Test BEB LH Ovulation Rapid Test Strip BEB H. pylori Antigen Rapid Test Famwell hCG Pregnancy Rapid Combo Test BEB hCG Pregnancy Rapid Test Strip Famwell hCG Pregnancy Rapid Test Strip BEB Multi-Drug Rapit Test

    Establishment Types

    Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device