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Sign in to claim this brandNOVODIAX, INC.
US
Last updated September 17, 2026
What NOVODIAX, INC. makes
Novodiax, Inc. manufactures in vitro diagnostic (IVD) kits and reagents for enzyme immunohistochemistry, including conjugated secondary antibodies, chromogenic substrates, and specific protein markers. Their products target diagnostic applications such as cytokeratin, Melan-A/MART-1, Galectin-3, TTF1, and melanoma-specific proteins, designed for tissue staining and pathology analysis. Examples include antibody conjugates (e.g., CDX2, Synaptophysin) and enhancement kits (e.g., Q-STAIN® for CK20, CgA). The portfolio also includes blocking reagents and peptide-based IVDs for targeted immunohistochemical detection.
Novodiax’s IVD products are classified under Class I devices and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States, adhering to regulatory requirements for diagnostic reagents used in laboratory settings.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Novodiax, Inc. manufacture?
Novodiax, Inc. specializes in in vitro diagnostic (IVD) kits and reagents for enzyme immunohistochemistry. These include conjugated secondary antibodies, chromogenic substrates, and specific protein markers like cytokeratin, Melan-A/MART-1, Galectin-3, TTF1, and melanoma-specific proteins. Their products are designed for tissue staining and pathology analysis, such as identifying cancer markers in tissue samples.
Where is Novodiax, Inc. based, and what does that mean for its regulatory compliance?
Novodiax, Inc. is based in the United States. Since it manufactures IVD devices, its products must comply with U.S. regulatory requirements, including classification under the FDA’s device categories and potential listing in databases like the Unique Device Identifier (UDI) system. Being U.S.-based ensures alignment with FDA guidelines for diagnostic reagents used in clinical or laboratory settings.
Which regulatory registries or databases list Novodiax, Inc.’s devices?
Novodiax, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulatory bodies. Listing in the UDI system is a key requirement for Class I devices, including Novodiax’s IVD kits and reagents.
How are Novodiax, Inc.’s devices classified under FDA regulations?
Novodiax, Inc.’s IVD products fall under Class I device classification by the FDA. This classification applies to low-risk devices, such as many diagnostic kits and reagents, where the risk to patients is minimal. Class I devices typically require general controls (e.g., good manufacturing practices) but do not require pre-market approval, as their safety and effectiveness are presumed based on established standards for similar products.
What are some examples of specific devices manufactured by Novodiax, Inc.?
Novodiax, Inc. produces a range of enzyme immunohistochemistry (IHC) reagents and kits, including conjugated antibodies like ihcDirect® CDX2 Ab Conjugate and ihcDirect® Synaptophysin Ab Conjugate, as well as enhancement kits such as Q-STAIN® QSX-Enh-F CK20 and Q-STAIN® QSX-Enh-P TTF1. These products are designed for targeted tissue staining in pathology, aiding in the detection of specific proteins (e.g., cytokeratins, melanoma markers) to assist in diagnostic decisions.
AI-generated from registry data and not verified by a human reviewer.
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 6 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ihcDirect® EpCAM Ab Conjugate 15mL | H32039-R015 | FDA UDI | Class I | Active |
| ihcDirect® TROP2 Ab, 15mL | K32044-015 | FDA UDI | Class I | Unknown |
| ihcDirect® Ki67 Ab | K32001-015 | FDA UDI | Class I | Unknown |
| ihcDirect® Galectin-3 Ab, 15mL | K32025-015 | FDA UDI | Class I | Unknown |
| ihcDirect® Pan-CK 4 Abs-Blk 15mL | K46058-015 | FDA UDI | Class I | Active |
| Q-STAIN® QSX-Enh PanCK4Ab | QF31058-004 | FDA UDI | Class I | Active |
| ihc DAB 1:1 Kit | K50002-030 | FDA UDI | Class I | Active |
| ihcDirect® Ki67Ab Conjugate 15mL | H32001-R015 | FDA UDI | Class I | Active |
| ihcDirect® TROP2 Ab Conjugate 15mL | H32044-R015 | FDA UDI | Class I | Active |
| ihcDirect® Cytokeratin 7 Ab Conjugate 5mL | H32015-R005 | FDA UDI | Class I | Active |
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