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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 3 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ihcDirect® Podoplanin Ab Conjugate 15mL | H31025-R015 | FDA UDI | Class I | Active |
| ihcDirect® Pan-CK 4 Abs Conjugate 10mL | H31058-R010 | FDA UDI | Class I | Active |
| ihcDirect® AE1/AE3 Abs | K31007-015 | FDA UDI | Class I | Active |
| ihcDirect® WT1 Ab-Enh, 15mL | K47045-015 | FDA UDI | Class I | Unknown |
| ihcDirect® Napsin A Ab Conjugate 5mL | H32043-R005 | FDA UDI | Class I | Active |
| ihcDirect® CDX2 Ab, 5mL | K32047-005 | FDA UDI | Class I | Unknown |
| ihcDirect® p40 Ab, 5mL | K32024-005 | FDA UDI | Class I | Unknown |
| ihcDirect® Mart-1 Ab Conjugate 5mL | H31009-R005 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-F PDPN | QF31025-004 | FDA UDI | Class I | Active |
| ihcDirect® SOX10 Ab, 15mL | K32040-015 | FDA UDI | Class I | Unknown |
| ihcDirect® TROP2 Ab Conjugate 5mL | H32044-R005 | FDA UDI | Class I | Active |
| DAB Kit | K50001-030 | FDA UDI | Class I | Active |
| ihcDirect® Cytokeratin 5 Ab | K32014-015 | FDA UDI | Class I | Unknown |
| ihcDirect® Pan-CK 4Abs-Blk | K46058-005 | FDA UDI | Class I | Unknown |
| ihcDirect® CD45 Ab | K31010-005 | FDA UDI | Class I | Unknown |
| ihcDirect® TTF1 Ab-Enh, 15mL | K47041-015 | FDA UDI | Class I | Unknown |
| Q-STAIN® QSX-Enh-F Gal-3 | QF32025-004 | FDA UDI | Class I | Active |
| ihcDirect® CDX2 Ab, 15mL | K32047-015 | FDA UDI | Class I | Unknown |
| ihcDirect® TTF1 Ab-Enh 15mL | K47041-015 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-P GFAP | QP32002-004 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh PRAME | QH32042-004 | FDA UDI | Class I | Active |
| ihcDirect® Vimentin Ab | K32021-015 | FDA UDI | Class I | Unknown |
| ihcDirect® SMMS-1 Ab Conjugate 15mL | H31024-R015 | FDA UDI | Class I | Active |
| QSX-Enh-P HER2 (ASR) | AP31063-004 | FDA UDI | Class I | Active |
| ihcDirect® TTF1 Ab Conjugate 5mL | H32041-R005 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-F GFAP | QF32002-004 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-P CK19 | QP32033-004 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh p40 | QF32024-004 | FDA UDI | Class I | Active |
| ihcDirect® Napsin A Ab-Enh, 15mL | K47043-015 | FDA UDI | Class I | Unknown |
| ihcDirect® Chromogranin A Ab Conjugate 5mL | H32035-R005 | FDA UDI | Class I | Active |
| ihcDirect® Cytokeratin 19 Ab Conjugate 15mL | H32033-R015 | FDA UDI | Class I | Active |
| ihcDirect® Synaptophysin Ab Conjugate 15mL | H32034-R015 | FDA UDI | Class I | Active |
| ihcDirect® TPO Ab Conjugate 5mL | H31032-R005 | FDA UDI | Class I | Active |
| ihcDirect® PRAME Ab-Enh 15mL | K47042-015 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-F TPO | QF31032-004 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-P Calponin | QP31026-004 | FDA UDI | Class I | Active |
| ihc CD34 Ab (3mL) | KF31046-003 | FDA UDI | Class I | Active |
| ihcDirect® Galectin-3 Ab Conjugate 5mL | H32025-R005 | FDA UDI | Class I | Active |
| ihcDirect® CEA Ab | K31038-005 | FDA UDI | Class I | Unknown |
| ihcDirect® AE1/AE3 Abs Conjugate 10mL | H31007-R010 | FDA UDI | Class I | Active |
| ihcDirect® Napsin A Ab-Enh 5mL | K47043-005 | FDA UDI | Class I | Active |
| ihc DAB 1:1 Kit | K50002-015 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh-F CD45 | QF31010-004 | FDA UDI | Class I | Active |
| ihcDirect® Cytokeratin 5 Ab-Blk | K47014-015 | FDA UDI | Class I | Unknown |
| ihcDirect® p40 Ab Conjugate 15mL | H32024-R015 | FDA UDI | Class I | Active |
| QSX-Enh-P ER (ASR) | AP32052-004 | FDA UDI | Class I | Active |
| ihcDirect® Cytokeratin 7 Ab | K32015-015 | FDA UDI | Class I | Unknown |
| ihcDirect® Mart-1 Ab-Blk 10mL | K46009-010 | FDA UDI | Class I | Active |
| ihcDirect® Vimentin Ab Conjugate 5mL | H32021-R005 | FDA UDI | Class I | Active |
| ihcDirect® PTH Ab Conjugate 5mL | H31028-R005 | FDA UDI | Class I | Active |
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