Diagnostic Manufacturers
Diagnostic Manufacturers
OEM-grade antibodies, bulk reagents, and custom manufacturing to power your diagnostic platforms — with regulatory documentation and supply continuity.
Building Blocks for Diagnostic Innovation
In vitro diagnostic manufacturers need raw material suppliers who understand the demands of regulated manufacturing — consistent quality, long-term supply security, complete traceability, and responsive technical collaboration. Enzo Life Sciences has supported the IVD industry for over four decades, providing critical antibodies, conjugates, calibrators, and biochemical components that form the foundation of diagnostic assays worldwide.
OEM Antibody Supply
High-quality monoclonal and polyclonal antibodies available in bulk quantities for integration into your diagnostic platforms. We offer custom conjugation (HRP, AP, biotin, fluorophores) and format optimization to meet your assay specifications.
Bulk Reagent Manufacturing
Scale-up production of buffers, substrates, conjugates, and biochemical components under cGMP-compliant conditions. Our manufacturing capabilities support batch sizes from milliliters to hundreds of liters with full lot documentation.
Regulatory Documentation
Complete regulatory support including Drug Master Files, Certificates of Analysis, stability data, and raw material specifications. We work with your regulatory team to provide the documentation needed for 510(k), CE-IVD, and other submissions.
Supply Security Agreements
Long-term supply agreements with safety stock provisions, change notification commitments, and dedicated account management. We understand that supply disruption in diagnostics can impact patient care.
Diagnostic Manufacturers — By the Numbers
Explore OEM Partnership Opportunities
Connect with our team to discuss your specific requirements and explore partnership opportunities.