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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 4 of 6
DeviceModel / ReferenceRegistriesClassStatus
ihcDirect® Cytokeratin 20 Ab Conjugate 15mL H32032-R015
FDA UDI
Class IActive
ihcDirect® Cytokeratin 5 Ab Conjugate 5mL H32014-R005
FDA UDI
Class IActive
ihcDirect® Cytokeratin 5 Ab-Blk 15mL K47014-015
FDA UDI
Class IActive
ihcDirect® SOX10 Ab-Enh 15mL K47040-015
FDA UDI
Class IActive
ihcDirect® Cytokeratin 5 Ab-Blk K47014-005
FDA UDI
Class IUnknown
ihcDirect® SOX10 Ab, 5mL K32040-005
FDA UDI
Class IUnknown
ihcDirect® EMA Ab Conjugate 5mL H31040-R005
FDA UDI
Class IActive
ihcDirect® Cytokeratin 20 Ab Conjugate 5mL H32032-R005
FDA UDI
Class IActive
ihcDirect® Pan-CK 4 Abs-Blk 10mL K46058-010
FDA UDI
Class IActive
ihcDirect® Napsin A Ab, 15mL K32043-015
FDA UDI
Class IUnknown
ihcDirect® AE1/AE3 Abs Conjugate 15mL H31007-R015
FDA UDI
Class IActive
ihcDirect® SOX10 Ab Conjugate 15mL H32040-R015
FDA UDI
Class IActive
ihcDirect® Calponin Ab Conjugate 5mL H31026-R005
FDA UDI
Class IActive
Q-STAIN® QSX-Enh-P CK8/18 QP31001-004
FDA UDI
Class IActive
ihc Enhancer 5mL D28020-R005
FDA UDI
Class IActive
ihcDirect® Napsin A Ab-Enh 15mL K47043-015
FDA UDI
Class IActive
ihcDirect® Mart-1 Ab-Blk K46009-010
FDA UDI
Class IUnknown
ihcDirect® Ki67 Ab Conjugate 5mL H32001-R005
FDA UDI
Class IActive
Q-STAIN® QSX-Enh-F WT-1 QF32045-004
FDA UDI
Class IActive
ihcDirect® TTF1 Ab, 15mL K32041-015
FDA UDI
Class IUnknown
ihc Enhancer Kit, 15mL K51011-015
FDA UDI
Class IUnknown
Q-STAIN® QSX-Enh-F CD34 QF31046-004
FDA UDI
Class IActive
ihcDirect® PRAME Ab, 5mL K32042-005
FDA UDI
Class IUnknown
ihcDirect® Pan-CK 4Abs-Blk K46058-015
FDA UDI
Class IUnknown
ihcDirect® Mart-1 Ab K31009-015
FDA UDI
Class IUnknown
Q-STAIN® QSX Blocker QC30005-004
FDA UDI
Class IActive
Q-STAIN® QSX-Enh-P CDX2 QP32047-004
FDA UDI
Class IActive
ihcDirect® Cytokeratin 20 Ab K32032-015
FDA UDI
Class IUnknown
Q-STAIN® QSX-Enh-P AE1/AE3 QP31007-004
FDA UDI
Class IActive
ihcDirect® CDX2 Ab Conjugate 15mL H32047-R015
FDA UDI
Class IActive
ihcDirect® SOX10 Ab-Enh, 5mL K47040-005
FDA UDI
Class IUnknown
Q-STAIN® QSX Enhancer QD28020-004
FDA UDI
Class IActive
ihcDirect® Galectin-3 Ab Conjugate 15mL H32025-R015
FDA UDI
Class IActive
ihcDirect® Pan-CK 4 Abs-Blk 5mL K46058-005
FDA UDI
Class IActive
ihcDirect® EpCAM Ab, 5mL K32039-005
FDA UDI
Class IUnknown
ihcDirect® Chromogranin A Ab, 15mL K32035-015
FDA UDI
Class IUnknown
ihcDirect® Napsin A Ab Conjugate 15mL H32043-R015
FDA UDI
Class IActive
ihcDirect® EMA Ab K31040-005
FDA UDI
Class IUnknown
ihcDirect® CD20 Ab K32029-015
FDA UDI
Class IUnknown
Q-STAIN® QSX-Enh-P Vimentin QP32021-004
FDA UDI
Class IActive
Q-Stain® Qsx Dab QC30018-002
FDA UDI
Class IActive
ihcDirect® WT1 Ab Conjugate 5mL H32045-R005
FDA UDI
Class IActive
ihcDirect® p120 Ab Conjugate 5mL H32046-R005
FDA UDI
Class IActive
ihcDirect® WT1 Ab, 15mL K32045-015
FDA UDI
Class IUnknown
Q-STAIN® X Autostainer IA01-001
FDA UDI
Class IActive
ihcDirect® CD45 Ab Conjugate 5mL H31010-R005
FDA UDI
Class IActive
Q-STAIN® QSX-Enh-F TROP2 QF32044-004
FDA UDI
Class IActive
ihcDirect® PRAME Ab, 15mL K32042-015
FDA UDI
Class IUnknown
ihcDirect® Pan-CK 4 Abs Conjugate 15mL H31058-R015
FDA UDI
Class IActive
ihcDirect® Napsin A Ab-Enh, 5mL K47043-005
FDA UDI
Class IUnknown

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