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Sign in to claim this brandNOVODIAX, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 3517 Breakwater Ave, Hayward, CA, 94545
- Website
- novodiax.com
- —
- —
- [email protected]
- Phone
- 5103423043
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3013043616
- DUNS Number
- 965326957
Catalogue (260)
Page 1 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ihcDirect® SMMS-1 Ab Conjugate 5mL | H31024-R005 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-F EMA | QF31040-004 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh CK20 | QF32032-004 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-F CgA | QF32035-004 | FDA UDI | Class I | Active |
| ihcDirect® CDX2 Ab Conjugate 5mL | H32047-R005 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-P TTF1 | QP32041-004 | FDA UDI | Class I | Active |
| ihc Common Blocker 15mL | C30005-015ML | FDA UDI | Class I | Active |
| ihcDirect® p120 Ab, 5mL | K32046-005 | FDA UDI | Class I | Unknown |
| ihcDirect® Calponin Ab | K31026-005 | FDA UDI | Class I | Unknown |
| ihcDirect® Mart-1 Ab Conjugate 15mL | H31009-R015 | FDA UDI | Class I | Active |
| ihcDirect® Synaptophysin Ab Conjugate 5mL | H32034-R005 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-P CD20 | QP32029-004 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-P PDPN | QP31025-004 | FDA UDI | Class I | Active |
| ihcDirect® Chromogranin A Ab Conjugate 15mL | H32035-R015 | FDA UDI | Class I | Active |
| ihcDirect® Cytokeratin 5 Ab-Blk 10mL | K47014-010 | FDA UDI | Class I | Active |
| ihcDirect® EpCAM Ab, 15mL | K32039-015 | FDA UDI | Class I | Unknown |
| ihcDirect® Pan-CK 4Abs-Blk | K46058-010 | FDA UDI | Class I | Unknown |
| ihcDirect® Mart-1 Ab-Blk 30mL | K46009-030 | FDA UDI | Class I | Active |
| ihcDirect® Pan-CK 4Abs | K31058-015 | FDA UDI | Class I | Unknown |
| Q-STAIN® QSX-Enh-F CK8/18 | QF31001-004 | FDA UDI | Class I | Active |
| ihcDirect® SOX10 Ab-Enh 5mL | K47040-005 | FDA UDI | Class I | Active |
| ihcDirect® TTF1 Ab-Enh 5mL | K47041-005 | FDA UDI | Class I | Active |
| ihcDirect® Cytokeratin 19 Ab | K32033-015 | FDA UDI | Class I | Unknown |
| ihcDirect® GFAP Ab | K32002-005 | FDA UDI | Class I | Unknown |
| ihcDirect® TPO Ab, 15mL | K31032-015 | FDA UDI | Class I | Unknown |
| ihcDirect® PRAME Ab-Enh 5mL | K47042-005 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-F PTH | QF31028-004 | FDA UDI | Class I | Active |
| ihcDirect® Cytokeratin 8/18 Ab Conjugate 15mL | H31001-R015 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-P TROP2 | QP32044-004 | FDA UDI | Class I | Active |
| ihcDirect® Galectin-3 Ab-Enh, 15mL | K47025-015 | FDA UDI | Class I | Unknown |
| ihcDirect® EMA Ab | K31040-015 | FDA UDI | Class I | Unknown |
| ihcDirect® E-Cadherin Ab, 15mL | K32036-015 | FDA UDI | Class I | Unknown |
| ihcDirect® SOX10 Ab-Enh, 15mL | K47040-015 | FDA UDI | Class I | Unknown |
| ihc Common Blocker 10mL | C30005-010ML | FDA UDI | Class I | Active |
| ihcDirect® CD20 Ab Conjugate 5mL | H32029-R005 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-P Ki67 | QP32001-004 | FDA UDI | Class I | Active |
| ihcDirect® Cytokeratin 8/18 Ab | K31001-005 | FDA UDI | Class I | Unknown |
| ihcDirect® CD45 Ab | K31010-015 | FDA UDI | Class I | Unknown |
| ihcDirect® CD20 Ab | K32029-005 | FDA UDI | Class I | Unknown |
| DAB Kit | K50001-015 | FDA UDI | Class I | Active |
| ihcDirect® Mart-1 Ab-Blk 5mL | K46009-005 | FDA UDI | Class I | Active |
| ihcDirect® SOX10 Ab Conjugate 5mL | H32040-R005 | FDA UDI | Class I | Active |
| ihc Common Blocker 5mL | C30005-005ML | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Dir PanCK4Ab | QH31058-004 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-P SMMS-1 | QP31024-004 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-P TPO | QP31032-004 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-F Calponin | QF31026-004 | FDA UDI | Class I | Active |
| ihcDirect® CD20 Ab Conjugate 15mL | H32029-R015 | FDA UDI | Class I | Active |
| ihcDirect® p120 Ab, 15mL | K32046-015 | FDA UDI | Class I | Unknown |
| ihcDirect® Pan-CK 4 Abs Conjugate 5mL | H31058-R005 | FDA UDI | Class I | Active |
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