BEUDAMED
    FDA Registration Active 🇺🇸 United States

    QUALIGEN, INC.

    Reg #: 2032087 · FEI: 3003355251 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    QUALIGEN, INC.
    Registration Number
    2032087
    FEI Number
    3003355251
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2042 CORTE DEL NOGAL
    City
    CARLSBAD
    State
    CA
    ZIP
    92011
    Country
    US

    Regulatory Submissions

    510(k) Number
    K003096

    Owner / Operator

    Firm Name
    QUALIGEN, INC.
    Operator Number
    9040045
    Address
    2042 CORTE DEL NOGAL, --
    City
    Carlsbad
    State
    CA
    Postal Code
    92011
    Country
    US
    Correspondent
    Scott A Doyle

    Products

    Device Name Product Code
    Calibrator, Secondary JIT
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    System, Test, Vitamin D MRG
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Radioimmunoassay, Free Thyroxine CEC
    Calibrator, Multi-Analyte Mixture JIX
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
    Visual, Pregnancy Hcg, Prescription Use JHI
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ

    Proprietary Names

    FastPack TPSA Calibrator FastPack® IP SHBG FastPack® IP Vitamin D Kit FAST PACK TSH IMMUNOASSAY FastPack Testo Immunoassay FastPack Free T4 Immunoassay FAST PACK (TM) ANALYZER SYSTEM FastPack Testo Calibrator FastPack hCG Immunoassay FastPack PSA Controls FastPack® Control Kit FastPack TSH Immunoassay FastPack PSA Verifier FastPack TPSA Immunoassay

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198