BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis)

    Reg #: 2032900 · FEI: 3004445302 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Diazyme Laboratories, Inc.
    Registration Number
    2032900
    FEI Number
    3004445302
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12889 GREGG CT
    City
    POWAY
    State
    CA
    ZIP
    92064
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160762

    Owner / Operator

    Firm Name
    Diazyme Laboratories, Inc.
    Operator Number
    9057184
    Address
    12889 Gregg Court, --
    City
    Poway
    State
    CA
    Postal Code
    92064
    Country
    US
    Correspondent
    Abhijit - Datta

    Products

    Device Name Product Code
    Assay, Glycosylated Hemoglobin LCP
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Calibrator, Secondary JIT

    Proprietary Names

    Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis) Diazyme Direct HbA1c Assay Calibrator Set Diazyme Direct HbA1c Assay Control Set

    Establishment Types

    Manufacture Medical Device