BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Nova Allegro HbA1c Assay

    Reg #: 3023162659 · FEI: 3023162659 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Nova Biomedical Corporation
    Registration Number
    3023162659
    FEI Number
    3023162659
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4 Enterprise Road
    City
    Billerica
    State
    MA
    ZIP
    01821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221326

    Owner / Operator

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

    Products

    Device Name Product Code
    Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica JQT
    Assay, Glycosylated Hemoglobin LCP

    Proprietary Names

    Nova Allegro HbA1c Assay Nova Allegro Analyzer

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device