BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NOVODIAX, INC.

    Reg #: 3013043616 · FEI: 3013043616 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    112
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    NOVODIAX, INC.
    Registration Number
    3013043616
    FEI Number
    3013043616
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3517 Breakwater Ave
    City
    Hayward
    State
    CA
    ZIP
    94545
    Country
    US

    Owner / Operator

    Firm Name
    Novodiax, Inc.
    Operator Number
    10053131
    Address
    3517 Breakwater Ave.
    City
    Hayward
    State
    CA
    Postal Code
    94545
    Country
    US

    Products

    Device Name Product Code
    Slide Stainer, Automated KPA
    General Purpose Reagent PPM
    Reagents, Specific, Analyte MVU
    Immunohistochemistry Reagents And Kits NJT

    Proprietary Names

    Q-STAIN X Autostainer ihc Blocker ihc Wash Buffer Kit (10x) ihc Magenta 1:1 Kit QSX Magenta QSX Blocker QSX Wash Buffer (10x) QSX-Enh-P PR QSX-Enh-P ER QSX-Enh-P HER-2 QSX DAB QSX-Enh-P CD45 ihcDirect Immunohistochemistry Kits ihc CD34 QSX-Enh-P SMMS-1 QSX-Enh-F CgA QSX-Enh p40 QSX-Enh-F Calponin ihc Enhancer Kits QSX-Enh-F CEA QSX-Enh-F PTH ihcDirect EMA Ab ihcDirect TTF1 Ab-Enh QSX-Enh-F GFAP QSX- Enh-F WT-1 QSX-Enh-P AE1/AE3 QSX-Enh-P EMA QSX-Enh-P SYN QSX-Enh-P CD20 QSX-Enh-F AE1/AE3 ihcDirect Calponin Ab QSX-Enh-P TTF1 QSX-Enh-P Vimentin ihcDirect Cytokeratin 7 Ab ihcDirect Galectin-3 Ab-Enh QSX-Enh PanCK4Abs QSX- Enh-F TROP2 ihcDirect EpCAM Ab QSX-Enh-P TPO QSX-Enh-P CgA ihcDirect Pan-CK 4Abs ihcDirect Mart-1 Kits ihcDirect Synaptophysin Ab QSX-Enh CK7 QSX-Enh-F CD20 QSX- Enh-F Gal-3 QSX-Enh-P PDPN QSX-Enh-P CK19 QSX-Enh CK5 QSX-Enh-P CK8/18 ihcDirect GFAP Ab QSX-Enh SOX10 ihcDirect Podoplanin Ab ihcDirect TROP2 Ab QSX-Enh EpCAM QSX- Enh-P TROP2 QSX-Enh-P Ki67 QSX-Enh-F SMMS-1 QSX-Enh-F Ki67 QSX-Enh-F SYN ihcDirect CK20 Ab QSX-Enh PRAME QSX-Enh-F PDPN QSX-Enh-F CK19 QSX-Enh-P Calponin ihcDirect CD45 Ab ihcDirect TPO Ab QSX-Enh-F EMA QSX-Enh-F CDX2 ihcDirect Ki67 Ab QSX-Enh Mart-1 QSX-Enh-F CK8/18 ihcDirect CK19 Ab QSX-Dir PanCK4Abs QSX-Enh-P CEA ihcDirect SOX10 Ab-Enh QSX Enhancer QSX-Enh-F CD45 ihcDirect AE1/AE3 Abs ihcDirect Cytokeratin 8/18 Ab ihcDirect Napsin A Ab-Enh QSX-Enh CK20 QSX- Enh-P Gal-3 ihcDirect Vimentin Ab ihcDirect WT1 Ab-Enh QSX-Enh-P CD34 ihc DAB 1:1 Kits ihcDirect E-Cadherin Ab-Enh QSX-Enh-P E-Cad QSX-Enh Napsin A DAB Kit ihcDirect Chromogranin A Ab QSX-Enh-P GFAP QSX- Enh-P WT-1 QSX-Enh p120 ihcDirect SMMS-1 Ab ihcDirect CDX2 Ab QSX-Enh-F E-Cad ihcDirect CEA Ab ihcDirect PTH Ab QSX-Enh-P CDX2 ihcDirect p40 Ab QSX-Enh-F TPO ihcDirect Cytokeratin 5 Kits QSX-Enh-F TTF1 QSX-Enh-F Vimentin ihcDirect CD20 Ab ihcDirect p120 Ab QSX-Enh-F CD34 ihcDirect PRAME Ab-Enh QSX-Enh-P PTH ihc SOX10

    Establishment Types

    Manufacture Medical Device