BEUDAMED
    FDA Registration Active 🇺🇸 United States

    True Urine SD Calibrator & Control set

    Reg #: 3011513373 · FEI: 3011513373 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VISION DIAGNOSTICS INC.
    Registration Number
    3011513373
    FEI Number
    3011513373
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    26689 St. Rd. 247, Suite 200
    City
    Branford
    State
    FL
    ZIP
    32008
    Country
    US

    Owner / Operator

    Firm Name
    Vision Diagnostics Inc
    Operator Number
    10048906
    Address
    26689 St. Rd 247, Suite 200
    City
    Branford
    State
    FL
    Postal Code
    32008
    Country
    US
    Correspondent
    Donna Suggs

    Products

    Device Name Product Code
    General Purpose Reagent PPM

    Proprietary Names

    True Urine SD Calibrator & Control set Specific Gravity Calibrator Kit (2x25 ml) Specific Gravity Screening Bulk Reagent Kit 1 Liter (9346 tests) Oxidant History Bulk Reagent Kit 1 Liter (10000) tests Urine Creatinine R1(1x50ml) R2(3x92ml) True Urine LD Reagent (Synthetic Urine) R1(4x50ml) R2(1x50ml) Urine Creatinine (1600 test) Beckman AU Series PH Reagent R1(5x 50ml) Oxidant History Reagent R1(3x60ml) R2(2x45ml) Oxidant History Calibrator & Controls (1 ea. 50ml low/hi ctl 1ea. 25ml cal) Urine Creatinine Control / Calibrators PH Calibrator Kit 25 ml each Level I 3 & Level II 10.5 Specific Gravity Control Kit (2x50 ml) True Urine SD Reagent (Synthetic Urine) R1(4x50ml) R2(1x50ml) PH Screening Reagent Kit 4x 50ml (1600 tests) Beckman AU Series Specific Gravity Screening Reagent 4x50ml 4x20ml 1600 test AU Series PH Screening Bulk Reagent Kit 1 Liter (6670 tests) Beckman AU Series Specific Gravity Index Reagent R1(3x50ml) R2(1x60ml) True Urine LD Bulk Reagent Kit 1 Liter (8335 tests) True Urine SD Bulk Reagent Kit 1 Liter (7692 tests) True Urine SD Reagent 4x50ml 4x20ml AU Series Urine Creatinine Bulk Reagent Kit 1 Liter (5814 tests) True Urine LD Reagent 4x50ml 4x20ml 1600 test AU Series PH Control Kit - low and high 50ml each True Urine LD Control set Oxidant History Adulterant Det. Reagent 4x50ml 4x20ml 1600 test (AU Series)

    Establishment Types

    Manufacture Medical Device