IVD Diagnostic Kits

USP <1208> filing rule now affects U.S.-bound CLIA reagents. Learn how FDA eSTAR extractables requirements, third-party lab summaries, and timing risks may impact exports.

Saudi SASO Extends GMP Origin Code Relief for Multiplex PCR Kits through Sept. 30, 2026. Learn the new documentation rules, CMO audit impact, and how exporters can keep shipments compliant.

USP <1208> takes effect for CLIA reagent exports, requiring validated extractables declarations for solvent systems, contact materials, and transport packaging. Learn how to avoid shipment refusal and audit risk.

Fluorescent microsphere reagents price in 2026 depends on more than quotes—learn the real cost drivers, hidden risks, and smart sourcing strategies to cut spend without sacrificing assay performance.