Ortho Diagnostic Systems, Inc.

Ortho Diagnostic Systems, Inc. manufactures in vitro diagnostic reagents and controls for coagulation testing, including APTT reagents (e.g., SYNTHASIL, SYNTHAFAX), plasminogen assays (e.g., ORTHOKROME*), and antibody detection kits for Epstein-Barr virus (e.g., EBV VCA-IGG ELISA, Epstein-Barr virus EA(D+R)-IGG). The company also produces pregnancy testing reagents (e.g., ORTHO RESULT PLUS/PREGNANCY) and controls for protein C assays (e.g., ORTHO ABNORMAL PROTEIN C CONTROL PLASMA), as well as coagulation system components (e.g., KOAGULAB* M). Additional products include enzyme immunoassays (e.g., ORTHO*PAP-IA) and spectrum-based diagnostic controls (e.g., ORTHO SPECTRUM III).

The portfolio includes devices classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) clearance database. These products are intended for laboratory use in the US, where the manufacturer is based.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.