BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ihcDirect SMMS-1 Ab

    Reg #: 3013043616 · FEI: 3013043616 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    102
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NOVODIAX, INC.
    Registration Number
    3013043616
    FEI Number
    3013043616
    Status
    Active
    Expiry Year
    2025
    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
    Immunohistochemistry Reagents And Kits NJT

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device