BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    SSI Diagnostica A/S

    Reg #: 9611882 · FEI: 3002808078 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    SSI Diagnostica A/S
    Registration Number
    9611882
    FEI Number
    3002808078
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2 Herredsvejen
    City
    Hilleroed Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K191184

    Owner / Operator

    Firm Name
    SSI Diagnostica A/S
    Operator Number
    10052749
    Address
    Herredsvejen 2
    City
    Hilleroed
    State
    Hovedstaden
    Postal Code
    3400
    Country
    DK
    Correspondent
    Marianne S Thorsen

    US Agent

    Business Name
    Techlab Inc.
    Contact Name
    Donna Link
    Address
    2001 Kraft Dr
    City
    Blacksburg
    State
    VA
    ZIP
    24060
    Country
    US
    Email
    [email protected]
    Phone
    540 9531664

    Products

    Device Name Product Code
    Antigens, All Groups, Streptococcus Spp. GTY
    Antisera, All Types, Escherichia Coli GNA
    Reagents, Specific, Analyte MVU
    Antisera, All Types, Streptococcus Pneumoniae GWC
    Antisera, All Groups, Streptococcus Spp. GTZ
    Legionella, Spp., Elisa MJH
    Antisera, All Groups, Salmonella Spp. GRM
    Antigens, All Types, Escherichia Coli GMZ
    Kit, Identification, Dermatophyte JSR
    Culture Media, Selective And Differential JSI
    Antigens, All Groups, Salmonella Spp. GRL

    Proprietary Names

    Pneumococcus strain S. pneumoniae strain Streptococcus strain E. coli Reagent Pneumococcus ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test Salmonella Streptococcus E.coli strain Dermatophyte and C. albicans Real Time PCR kit Culture Media Salmonella strains

    Establishment Types

    Manufacture Medical Device