BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Control FLQ Vitamin D

    Reg #: 3011325031 · FEI: 3011325031 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    37
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AALTO SCIENTIFIC LTD.
    Registration Number
    3011325031
    FEI Number
    3011325031
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    230 Technology Pkwy
    City
    Eatonton
    State
    GA
    ZIP
    31024
    Country
    US

    Owner / Operator

    Firm Name
    AALTO SCIENTIFIC LTD.
    Operator Number
    9000089
    Address
    230 Technology Parkway, --
    City
    Eatonton
    State
    GA
    Postal Code
    31024
    Country
    US
    Correspondent
    Robert - Burda

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    Control FLQ Vitamin D Linearity FLQ Vitamin D Control LQ HbA1c Control FD HbA1c Linearity FD BNP Siemens Atellica/Centaur Linearity FD HbA1c Glycohemoglobin A1c Controls Linearity LQ ASO Linearity FD Procalcitonin for Abbott Systems Linearity LQ TIBC for Ortho Vitros Linearity FLQ HbA1c Linearity DROP LQ Fructosamine for Roche Systems Control LQ hs-CRP Cal Ver LQ T-Uptake Tosoh AIA Linearity FD UIBC Control DROP LQ Blood Glucose Linearity FD General Chemistry Panel 2 for Ortho Vitros Linearity LQ Vitamin D Linearity LQ Beta-Hydroxybutyric Acid Control LQ Vitamin D Linearity FLQ Vitamin D for Ortho Vitros Linearity LQ Vitamin D Roche Systems Linearity LQ Homocysteine Siemens Atellica/Centaur Linearity LQ hs-CRP Linearity LQ Homocysteine Linearity FD iPTH for Ortho Vitros Linearity FD iPTH for Roche Systems Linearity FD iPTH Siemens Atellica Linearity FD iPTH for Abbott Systems Linearity LQ Cystatin C Linearity FD Procalcitonin for Siemens Atellica Linearity FLQ Anti-Mullerian Hormone for Roche Systems Linearity FLQ Vitamin D for Roche Systems Method Val FD GFAP for bioMerieux VIDAS® TBI (GFAP) Control FD for bioMerieux VIDAS® NEPHROCLEAR CCL14 Linearity LQ hs-CRP for Ortho Vitros Method Val FD UCH-L1 for bioMerieux VIDAS® TBI (UCH-L1)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device