Diazyme Laboratories, Inc.

Diazyme Laboratories, Inc. is a San Diego-based manufacturer of diagnostic reagents and automated clinical chemistry analyzers. The company specializes in enzyme immunoassay and immunoturbidimetric technologies for automated laboratory analyzers. Product portfolio includes assays for cardiovascular markers (Lp-PLA2 via PLAC® Test, FDA-cleared), cancer markers (kappa and lambda free light chains), sepsis markers (procalcitonin), renal function (cystatin C, creatinine), liver function (total bile acids), diabetic markers (glycated serum protein), gastrointestinal health (calprotectin, lactoferrin), neurodegenerative biomarkers (phosphorylated tau variants, amyloid-beta, neurofilament light chain—mostly in development), and specialty assays (pancreatic elastase, serum amyloid A, vitamin D). The company manufactures the DZ-Lite c270 clinical chemistry analyzer, a fully automated system capable of 270 tests/hour supporting 1–4 reagent assays. Diazyme holds FDA 510(k) clearances for multiple assays and CLIA certification for US distribution. The company serves clinical laboratories, hospitals, and diagnostics networks with liquid-stable, ready-to-use reagent systems compatible with major automated analyzers. Manufacturing and distribution capabilities support both domestic (US) and international markets.