Novodiax Inc

FDA Filings

This page includes the latest FDA filings for Novodiax Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3013043616
FEI Number3013043616
NameNOVODIAX, INC.
Owner & OperatorNovodiax, Inc.
Contact Address3517 Breakwater Ave.
Hayward CA 94545 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3517 Breakwater Ave
Hayward, CA 94545 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P CgA QP32035-0042023-11-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F CgA QF32035-0042023-11-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F TROP2 QF32044-0042023-11-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P TROP2 QP32044-0042023-11-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F Gal-3 QF32025-0042023-11-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P Gal-3 QP32025-0042023-11-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F WT-1 QF32045-0042023-11-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P WT-1 QP32045-0042023-11-29
NOVODIAX, INC.
QSX-Enh-P PR (ASR) AP32053-0042023-03-28
NOVODIAX, INC.
QSX-Enh-P ER (ASR) AP32052-0042023-03-28
NOVODIAX, INC.
QSX-Enh-P HER2 (ASR) AP31063-0042023-03-28
NOVODIAX, INC.
ihc CD34 Ab (5mL) F31046-R005 / KF31046-0052023-03-28
NOVODIAX, INC.
ihc CD34 Ab (3mL) F31046-R003 / KF31046-0032023-03-28
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P CD34 QP31046-0042023-03-28
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F CD34 QF31046-0042023-03-28
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P E-Cad QP32036-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P CDX2 QP32047-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P TPO QP31032-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P PTH QP31028-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P CK19 QP32033-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P EMA QP31040-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F E-Cad QF32036-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F CDX2 QF32047-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F Vimentin QF32021-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F CD20 QF32029-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F GFAP QF32002-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F TPO QF31032-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F PTH QF31028-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F CK19 QF32033-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F EMA QF31040-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P TTF1 QP32041-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P SYN QP32034-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P Ki67 QP32001-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F TTF1 QF32041-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F SYN QF32034-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F Ki67 QF32001-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P Vimentin QP32021-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P CD20 QP32029-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P GFAP QP32002-0042022-07-29
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P CD45 QP31010-0042022-05-23
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P CEA QP31038-0042022-05-23
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P PDPN QP31025-0042022-05-23
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P AE1/AE3 QP31007-0042022-05-23
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P Calponin QP31026-0042022-05-23
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P CK8/18 QP31001-0042022-05-23
NOVODIAX, INC.
Q-STAIN® QSX-Enh-P SMMS-1 QP31024-0042022-05-23
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F CD45 QF31010-0042022-05-23
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F CEA QF31038-0042022-05-23
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F PDPN 2022-05-23
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F AE1/AE3 QF31007-0042022-05-23
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F Calponin QF31026-0042022-05-23
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F CK8/18 QF31001-0042022-05-23
NOVODIAX, INC.
Q-STAIN® QSX-Enh-F SMMS-1 QF31024-0042022-05-23
NOVODIAX, INC.
Q-STAIN® X Autostainer IA01-0012022-02-14
NOVODIAX, INC.
Q-STAIN® QSX-Dir PanCK4Ab QH31058-0042022-02-09
NOVODIAX, INC.
Q-STAIN® QSX DAB QC30018-0022022-02-09
NOVODIAX, INC.
Q-STAIN® QSX Enhancer QD28020-0042022-02-09
NOVODIAX, INC.
Q-STAIN® QSX Blocker QC30005-0042022-02-09
NOVODIAX, INC.
Q-STAIN® QSX-Enh PRAME QH32042-0042022-02-09
NOVODIAX, INC.
Q-STAIN® QSX-Enh SOX10 QH32040-0042022-02-09
NOVODIAX, INC.
Q-STAIN® QSX-Enh EpCAM QH32039-0042022-02-09
NOVODIAX, INC.
Q-STAIN® QSX-Enh PanCK4Ab QF31058-0042022-02-09
NOVODIAX, INC.
Q-STAIN® QSX-Enh CK20 QF32032-0042022-02-09
NOVODIAX, INC.
Q-STAIN® QSX-Enh CK7 QF32015-0042022-02-09
NOVODIAX, INC.
Q-STAIN® QSX-Enh p40 QF32024-0042022-02-09
NOVODIAX, INC.
Q-STAIN® QSX-Enh CK5 QF32014-0042022-02-09
NOVODIAX, INC.
Q-STAIN® QSX-Enh Mart-1 QF31009-0042022-02-09
NOVODIAX, INC.
ihcDirect® Cytokeratin 7 Ab Conjugate 15mL K32015-0152021-08-30
NOVODIAX, INC.
ihcDirect® Cytokeratin 7 Ab Conjugate 5mL K32015-0052021-08-30
NOVODIAX, INC.
ihcDirect® CD45 Ab Conjugate 15mL K31010-0152021-08-30
NOVODIAX, INC.
ihcDirect® CD45 Ab Conjugate 5mL K31010-0052021-08-30
NOVODIAX, INC.
ihcDirect® AE1/AE3 Abs 10mL 2021-08-30
NOVODIAX, INC.
ihcDirect® AE1/AE3 Abs Conjugate 15mL K31007-0152021-08-30
NOVODIAX, INC.
ihcDirect® AE1/AE3 Abs Conjugate 10mL K31007-0102021-08-30
NOVODIAX, INC.
ihcDirect® AE1/AE3 Abs Conjugate 5mL K31007-0052021-08-30
NOVODIAX, INC.
ihcDirect® Synaptophysin Ab Conjugate 15mL K32034-0152021-08-30
NOVODIAX, INC.
ihcDirect® Synaptophysin Ab Conjugate 5mL K32034-0052021-08-30
NOVODIAX, INC.
ihcDirect® Cytokeratin 19 Ab Conjugate 15mL K32033-0152021-08-30
NOVODIAX, INC.
ihcDirect® Cytokeratin 19 Ab Conjugate 5mL K32033-0052021-08-30
NOVODIAX, INC.
ihcDirect® Cytokeratin 20 Ab Conjugate 15mL K32032-0152021-08-30
NOVODIAX, INC.
ihcDirect® Cytokeratin 20 Ab Conjugate 5mL K32032-0052021-08-30
NOVODIAX, INC.
ihcDirect® SOX10 Ab-Enh 15mL 2021-08-30
NOVODIAX, INC.
ihcDirect® SOX10 Ab-Enh 5mL 2021-08-30
NOVODIAX, INC.
ihcDirect® SOX10 Ab Conjugate 15mL K32040-0152021-08-30
NOVODIAX, INC.
ihcDirect® SOX10 Ab Conjugate 5mL K32040-0052021-08-30
NOVODIAX, INC.
ihcDirect® Cytokeratin 8/18 Ab Conjugate 15mL K31001-0152021-08-30
NOVODIAX, INC.
ihcDirect® Cytokeratin 8/18 Ab Conjugate 5mL K31001-0052021-08-30
NOVODIAX, INC.
ihcDirect® Cytokeratin 5 Ab-Blk 15mL 2021-08-30
NOVODIAX, INC.
ihcDirect® Cytokeratin 5 Ab-Blk 10mL 2021-08-30
NOVODIAX, INC.
ihcDirect® Cytokeratin 5 Ab-Blk 5mL 2021-08-30
NOVODIAX, INC.
ihcDirect® Cytokeratin 5 Ab Conjugate 15mL K47014-0152021-08-30
NOVODIAX, INC.
ihcDirect® Cytokeratin 5 Ab Conjugate 10mL K47014-0102021-08-30
NOVODIAX, INC.
ihcDirect® Cytokeratin 5 Ab Conjugate 5mL K47014-0052021-08-30
NOVODIAX, INC.
ihcDirect® Mart-1 Ab-Blk 30mL 2021-08-30
NOVODIAX, INC.
ihcDirect® Mart-1 Ab-Blk 15mL 2021-08-30
NOVODIAX, INC.
ihcDirect® Mart-1 Ab-Blk 10mL 2021-08-30
NOVODIAX, INC.
ihcDirect® Mart-1 Ab-Blk 5mL 2021-08-30
NOVODIAX, INC.
ihcDirect® Mart-1 Ab Conjugate 15mL K46009-0152021-08-30
NOVODIAX, INC.
ihcDirect® Mart-1 Ab Conjugate 10mL K46009-0102021-08-30
NOVODIAX, INC.
ihcDirect® Mart-1 Ab Conjugate 5mL K46009-0052021-08-30
NOVODIAX, INC.
ihc Wash Buffer Kit (10x)2018-01-30
NOVODIAX, INC.
ihc Magenta 1:1 Kit2018-01-30
NOVODIAX, INC.
ihc Blocker2018-01-30
NOVODIAX, INC.
ihcDirect Vimentin Ab2016-11-02
NOVODIAX, INC.
ihcDirect SMMS-1 Kits2016-11-02
NOVODIAX, INC.
ihcDirect Podoplanin Kits2016-11-02
NOVODIAX, INC.
ihcDirect Pan-CK 4Abs2016-11-02
NOVODIAX, INC.
ihcDirect Mart-1 Kits2016-11-02
NOVODIAX, INC.
ihcDirect Ki67 Ab2016-11-02
NOVODIAX, INC.
ihcDirect Immunohistochemistry Kits2016-11-02
NOVODIAX, INC.
ihcDirect GFAP Kits2016-11-02
NOVODIAX, INC.
ihcDirect EMA Ab2016-11-02
NOVODIAX, INC.
ihcDirect Cytokeratin 8/18 Kits2016-11-02
NOVODIAX, INC.
ihcDirect Cytokeratin 7 Kits2016-11-02
NOVODIAX, INC.
ihcDirect Cytokeratin 5 Kits2016-11-02
NOVODIAX, INC.
ihcDirect Calponin Kits2016-11-02
NOVODIAX, INC.
ihcDirect CEA Ab2016-11-02
NOVODIAX, INC.
ihcDirect CD45 Ab2016-11-02
NOVODIAX, INC.
ihcDirect CD20 Ab2016-11-02
NOVODIAX, INC.
ihcDirect AE1/AE3 Abs2016-11-02
NOVODIAX, INC.
ihc DAB 1:1 Kits2016-11-02
NOVODIAX, INC.
DAB Kit2016-11-02

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