Ortho-Clinical Diagnostics - FDA 510(k) Cleared Devices
Ortho-Clinical Diagnostics is an in vitro diagnostics company specializing in clinical laboratory testing and immunohematology. Now part of QuidelOrtho, the brand operates with global research and development centered in Rochester, New York.
The company maintains a strong FDA 510(k) regulatory record with 38 FDA 510(k) clearances from 38 total submissions since 1999. Recent clearances span chemistry devices, immunology assays, and microbiology reagents, reflecting the company's focus on diagnostic platforms and assays for disease detection and blood compatibility testing.
The VITROS Immunodiagnostic Products line represents the company's core portfolio, encompassing reagent packs for tumor markers, cardiac biomarkers, infectious disease screening, and hormone testing. These platforms serve clinical laboratories worldwide and support transfusion medicine and general chemistry diagnostics.
The latest FDA 510(k) clearance in 2024 demonstrates continued regulatory activity and product innovation. Explore the complete clearance history, device names, product codes, and approval dates in the database below.
FDA 510(k) cleared devices by Ortho-Clinical Diagnostics
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