BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS

    Reg #: 3004193489 · FEI: 3004193489 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    33
    Establishment Types
    5
    Classifications
    13

    Registration Details

    Registration Name
    NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS
    Registration Number
    3004193489
    FEI Number
    3004193489
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    39 Manning Rd
    City
    Billerica
    State
    MA
    ZIP
    01821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K091547

    Owner / Operator

    Firm Name
    NOVA BIOMEDICAL CORP.
    Operator Number
    1219029
    Address
    200 PROSPECT ST., --
    City
    Waltham
    State
    MA
    Postal Code
    02454
    Country
    US

    Products

    Device Name Product Code
    Glucose Oxidase, Glucose CGA
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    System, Test, Blood Glucose, Over The Counter NBW
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Glucose Dehydrogenase, Glucose LFR
    Acid, Lactic, Enzymatic Method KHP
    Prescription Use Blood Glucose Meter For Near-Patient Testing PZI
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Hemoglobinometer GIG
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Uric Acid Test System For At Home Prescription Use PTC
    Electrode, Ion Based, Enzymatic, Creatinine CGL
    Oximeter To Measure Hemoglobin GLY

    Proprietary Names

    Nova Max Plus StatStrip Xpress Nova Max Nova Max One Nova StatStrip Xpress Nova StatStrip Nova StatStrip Lactate True Focus Pro Focus Pro Focus Menarini GlycoPC Menarini Glucomen Lx Nova Pro B-Ketone Test Strips Nova StatStrip Xpress Glucose and B-Ketone Meter Nova Pro Glucose and B-Ketone Controls and Linearity Solutions 51184 Menarini Glucofix Mio Premium Nova StatStrip Glucose and B-Ketone Controls and Linearity Solutions StatStrip B-Ketone Test Strips Nova StatStrip Glucose and B-Ketone Meter Nipro StatStrip XP3 Nova Pro Glucose Test Strips Nova Pro Glucose and B-Ketone Meter 51185 Menarini Glucofix Mio Premium StatStrip Nova Allegro System StatStrip Xpress Glucose Meter Nova One StatStrip Glucose Hospital Meter System Nova Max Link StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter LifeScan OneTouch StatStrip StatStrip Xpress 2 Glucose Hospital Meter StatSensor

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Manufacture Device in the United States for Export Only Remanufacture Medical Device