FARMINGDALE, NY — February 2026 — Enzo Life Sciences, Inc. announced that it has successfully completed the renewal audit for its ISO 13485:2016 certification, the internationally recognized quality management system standard for organizations involved in the design and manufacture of medical devices and in-vitro diagnostic (IVD) products.

The certification, issued by a leading global certification body, confirms that Enzo's quality management system meets the stringent requirements for the design, development, production, installation, and servicing of medical devices and IVD products.

Commitment to Quality

"Quality is foundational to everything we do at Enzo," said the VP of Quality. "This renewal reflects our ongoing commitment to maintaining the highest standards in our manufacturing processes, from incoming material inspection through final product release. Our customers in the clinical diagnostics, pharmaceutical, and research markets depend on the consistency and reliability of our products."

Certification Scope

• Design and manufacture of labeled nucleotides, probes, and detection reagents
• Production of immunoassay kits for clinical and research applications
• Custom manufacturing and OEM production services
• Storage and distribution of temperature-sensitive biological reagents

Enzo maintains a comprehensive quality system that includes documented procedures for change control, CAPA (Corrective and Preventive Action), supplier management, equipment calibration, and environmental monitoring.