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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 2 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Q-STAIN® QSX-Enh-P CD45 | QP31010-004 | FDA UDI | Class I | Active |
| ihcDirect® Vimentin Ab | K32021-005 | FDA UDI | Class I | Unknown |
| Q-STAIN® QSX-Enh EpCAM | QH32039-004 | FDA UDI | Class I | Active |
| ihcDirect® TPO Ab Conjugate 15mL | H31032-R015 | FDA UDI | Class I | Active |
| ihcDirect® Ki67 Ab | K32001-005 | FDA UDI | Class I | Unknown |
| Q-STAIN® QSX-Enh-P CEA | QP31038-004 | FDA UDI | Class I | Active |
| ihcDirect® CEA Ab Conjugate 5mL | H31038-R005 | FDA UDI | Class I | Active |
| ihcDirect® p40 Ab Conjugate 5mL | H32024-R005 | FDA UDI | Class I | Active |
| ihcDirect® Cytokeratin 7 Ab | K32015-005 | FDA UDI | Class I | Unknown |
| ihcDirect® Galectin-3 Ab-Enh 5mL | K47025-005 | FDA UDI | Class I | Active |
| ihcDirect® PRAME Ab Conjugate 15mL | H32042-R015 | FDA UDI | Class I | Active |
| ihcDirect® Calponin Ab | K31026-015 | FDA UDI | Class I | Unknown |
| Q-STAIN® QSX-Enh SOX10 | QH32040-004 | FDA UDI | Class I | Active |
| ihcDirect® GFAP Ab | K32002-015 | FDA UDI | Class I | Unknown |
| ihcDirect® Galectin-3 Ab, 5mL | K32025-005 | FDA UDI | Class I | Unknown |
| ihcDirect® Galectin-3 Ab-Enh 15mL | K47025-015 | FDA UDI | Class I | Active |
| ihcDirect® Cytokeratin 20 Ab | K32032-005 | FDA UDI | Class I | Unknown |
| ihcDirect® Cytokeratin 5 Ab-Blk | K47014-010 | FDA UDI | Class I | Unknown |
| Q-STAIN® QSX-Enh-P WT-1 | QP32045-004 | FDA UDI | Class I | Active |
| ihcDirect® CEA Ab | K31038-015 | FDA UDI | Class I | Unknown |
| Q-STAIN® QSX-Enh-F AE1/AE3 | QF31007-004 | FDA UDI | Class I | Active |
| ihcDirect® Mart-1 Ab-Blk | K46009-005 | FDA UDI | Class I | Unknown |
| ihcDirect® AE1/AE3 Abs Conjugate 5mL | H31007-R005 | FDA UDI | Class I | Active |
| ihcDirect® PRAME Ab-Enh, 15mL | K47042-015 | FDA UDI | Class I | Unknown |
| ihcDirect® AE1/AE3 Abs | K31007-005 | FDA UDI | Class I | Active |
| ihcDirect® GFAP Ab Conjugate 5mL | H32002-R005 | FDA UDI | Class I | Active |
| ihcDirect® TPO Ab, 5mL | K31032-005 | FDA UDI | Class I | Unknown |
| Q-STAIN® QSX-Enh-F CK19 | QF32033-004 | FDA UDI | Class I | Active |
| ihcDirect® EpCAM Ab Conjugate 5mL | H32039-R005 | FDA UDI | Class I | Active |
| ihcDirect® Cytokeratin 8/18 Ab | K31001-015 | FDA UDI | Class I | Unknown |
| ihcDirect® SMMS-1 Ab | K31024-015 | FDA UDI | Class I | Unknown |
| ihc CD34 Ab (5mL) | KF31046-005 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-F CDX2 | QF32047-004 | FDA UDI | Class I | Active |
| ihcDirect® E-Cadherin Ab Conjugate 5mL | H32036-R005 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-F TTF1 | QF32041-004 | FDA UDI | Class I | Active |
| ihcDirect® WT1 Ab-Enh, 5mL | K47045-005 | FDA UDI | Class I | Unknown |
| ihcDirect® Cytokeratin 5 Ab-Blk 5mL | K47014-005 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-F Ki67 | QF32001-004 | FDA UDI | Class I | Active |
| ihcDirect® PTH Ab Conjugate 15mL | H31028-R015 | FDA UDI | Class I | Active |
| ihcDirect® Cytokeratin 5 Ab Conjugate 10mL | H32014-R010 | FDA UDI | Class I | Active |
| ihcDirect® TTF1 Ab Conjugate 15mL | H32041-R015 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-P CD34 | QP31046-004 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-F Vimentin | QF32021-004 | FDA UDI | Class I | Active |
| ihcDirect® PTH Ab, 5mL | K31028-005 | FDA UDI | Class I | Unknown |
| Q-STAIN® QSX-Enh-P SYN | QP32034-004 | FDA UDI | Class I | Active |
| ihcDirect® Cytokeratin 5 Ab Conjugate 15mL | H32014-R015 | FDA UDI | Class I | Active |
| ihcDirect® TROP2 Ab, 5mL | K32044-005 | FDA UDI | Class I | Unknown |
| Q-STAIN® QSX-Enh-F SYN | QF32034-004 | FDA UDI | Class I | Active |
| ihcDirect® Vimentin Ab Conjugate 15mL | H32021-R015 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-F CD20 | QF32029-004 | FDA UDI | Class I | Active |
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