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NOVODIAX, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
3517 Breakwater Ave, Hayward, CA, 94545
Website
novodiax.com
LinkedIn
—
Facebook
—
Phone
5103423043
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3013043616
DUNS Number
965326957

Catalogue (260)

Page 5 of 6
DeviceModel / ReferenceRegistriesClassStatus
ihcDirect® p120 Ab Conjugate 15mL H32046-R015
FDA UDI
Class IActive
Q-STAIN® QSX-Enh CK7 QF32015-004
FDA UDI
Class IActive
ihcDirect® EMA Ab Conjugate 15mL H31040-R015
FDA UDI
Class IActive
ihcDirect® SMMS-1 Ab K31024-005
FDA UDI
Class IUnknown
ihcDirect® WT1 Ab, 5mL K32045-005
FDA UDI
Class IUnknown
ihcDirect® CEA Ab Conjugate 15mL H31038-R015
FDA UDI
Class IActive
ihcDirect® Cytokeratin 19 Ab Conjugate 5mL H32033-R005
FDA UDI
Class IActive
ihcDirect® WT1 Ab Conjugate 15mL H32045-R015
FDA UDI
Class IActive
Q-STAIN® QSX-Enh-P E-Cad QP32036-004
FDA UDI
Class IActive
ihcDirect® Podoplanin Ab K31025-005
FDA UDI
Class IUnknown
ihcDirect® E-Cadherin Ab Conjugate 15mL H32036-R015
FDA UDI
Class IActive
Q-STAIN® QSX-Enh-F E-Cad QF32036-004
FDA UDI
Class IActive
Q-STAIN® QSX-Enh Mart-1 QF31009-004
FDA UDI
Class IActive
ihcDirect® Mart-1 Ab Conjugate 10mL H31009-R010
FDA UDI
Class IActive
ihcDirect® Synaptophysin Ab, 5mL K32034-005
FDA UDI
Class IUnknown
ihcDirect® Cytokeratin 7 Ab Conjugate 15mL H32015-R015
FDA UDI
Class IActive
Q-STAIN® QSX-Enh-F CEA QF31038-004
FDA UDI
Class IActive
ihcDirect® PTH Ab, 15mL K31028-015
FDA UDI
Class IUnknown
QSX-Enh-P PR (ASR) AP32053-004
FDA UDI
Class IActive
ihcDirect® PRAME Ab-Enh, 5mL K47042-005
FDA UDI
Class IUnknown
Q-STAIN® QSX-Enh-F SMMS-1 QF31024-004
FDA UDI
Class IActive
ihcDirect® Cytokeratin 8/18 Ab Conjugate 5mL H31001-R005
FDA UDI
Class IActive
ihcDirect® Mart-1 Ab-Blk K46009-015
FDA UDI
Class IUnknown
ihcDirect® E-Cadherin Ab, 5mL K32036-005
FDA UDI
Class IUnknown
Q-STAIN® QSX-Enh-P CgA QP32035-004
FDA UDI
Class IActive
Q-STAIN® QSX-Enh CK5 QF32014-004
FDA UDI
Class IActive
ihcDirect® Chromogranin A Ab, 5mL K32035-005
FDA UDI
Class IUnknown
ihcDirect® E-Cadherin Ab-Enh, 15mL K47036-015
FDA UDI
Class IUnknown
ihcDirect® E-Cadherin Ab-Enh, 5mL K47036-005
FDA UDI
Class IUnknown
ihc Enhancer 15mL D28020-R015
FDA UDI
Class IActive
ihcDirect® Cytokeratin 19 Ab K32033-005
FDA UDI
Class IUnknown
Q-STAIN® QSX-Enh-P Gal-3 QP32025-004
FDA UDI
Class IActive
ihcDirect® Podoplanin Ab Conjugate 5mL H31025-R005
FDA UDI
Class IActive
ihcDirect® CD45 Ab Conjugate 15mL H31010-R015
FDA UDI
Class IActive
ihc Enhancer Kit, 30mL K51011-030
FDA UDI
Class IActive
ihcDirect® PRAME Ab Conjugate 5mL H32042-R005
FDA UDI
Class IActive
ihcDirect® Galectin-3 Ab-Enh, 5mL K47025-005
FDA UDI
Class IUnknown
ihcDirect® TTF1 Ab, 5mL K32041-005
FDA UDI
Class IUnknown
ihcDirect® Podoplanin Ab K31025-015
FDA UDI
Class IUnknown
Q-STAIN® QSX-Enh-P EMA QP31040-004
FDA UDI
Class IActive
ihcDirect® Mart-1 Ab-Blk 15mL K46009-015
FDA UDI
Class IActive
Q-STAIN® QSX-Enh-P PTH QP31028-004
FDA UDI
Class IActive
ihcDirect® Mart-1 Ab-Blk K46009-030
FDA UDI
Class IUnknown
ihcDirect® GFAP Ab Conjugate 15mL H32002-R015
FDA UDI
Class IActive
ihcDirect® Calponin Ab Conjugate 15mL H31026-R015
FDA UDI
Class IActive
ihcDirect® Napsin A Ab, 5mL K32043-005
FDA UDI
Class IUnknown
ihcDirect® p40 Ab, 15mL K32024-015
FDA UDI
Class IUnknown
ihcDirect® AE1/AE3 Abs 10mL K31007-010
FDA UDI
Class IActive
ihcDirect® Chromogranin A Ab, 15mL K32034-015
FDA UDI
Class IUnknown
ihcDirect® TTF1 Ab-Enh, 5mL K47041-005
FDA UDI
Class IUnknown

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