The U.S. Food and Drug Administration ("FDA") has granted QuidelOrtho Corporation ("QuidelOrtho"), a global leader of in vitro diagnostics, 510(k) clearance for the VITROS hs Troponin I Reagent Pack (the "VITROS h's Troponin I Assay"). The assay is intended for the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) to aid in the diagnosis of myocardial infarction (MI). The VITROS Systems are built on dry-slide, MicroWell and INTELLICHECK??
Technologies designed to deliver workflow efficiency, reliability and quality clinical results in laboratories worldwide. The commercial rollout for U.S. laboratories operating VITROS Systems will begin later this year. For ordering information, validation support or technical documentation, customers should contact their QuidelOrtho representative.
QuidelOrtho Corporation is engaged in vitro diagnostics, developing and manufacturing intelligent solutions. The Company sells its products directly to end users through a direct sales force and through a network of distributors, for professional use in physician offices, hospitals, clinical laboratories, reference laboratories, urgent care clinics, universities, retail clinics, pharmacies, wellness screening centers, other point-of-care (POC) settings, blood banks and donor centers, as well as for individual, non-professional, over the counter (OTC) use. The Company provides diagnostic testing solutions under various brand names, including AdenoPlus, BIOVUE, FreshCells, InflammaDry, Lyra, MeterPro, MicroVue, Ortho, Ortho Clinical Diagnostics, Ortho Connect, Ortho Plus, Ortho Vision, QuickVue, Quidel, QuidelOrtho, QVue, Savanna, Sofia, Solana, Thyretain, Triage, Virena, Vitros among others. It provides support for its customers across more than 130 countries and territories.
This super rating is the result of a weighted average of the rankings based on the following ratings: Global Valuation (Composite), EPS Revisions (4 months), and Visibility (Composite). We recommend that you carefully review the associated descriptions.
Investor
Investor
This super composite rating is the result of a weighted average of the rankings based on the following ratings: Fundamentals (Composite), Global Valuation (Composite), EPS Revisions (1 year), and Visibility (Composite). We recommend that you carefully review the associated descriptions.
Global
Global
This composite rating is the result of an average of the rankings based on the following ratings: Fundamentals (Composite), Valuation (Composite), Financial Estimates Revisions (Composite), Consensus (Composite), and Visibility (Composite). The company must be covered by at least 4 of these 5 ratings for the calculation to be performed. We recommend that you carefully review the associated descriptions.
Quality
Quality
This composite rating is the result of an average of the rankings based on the following ratings: Capital Efficiency (Composite), Quality of Financial Reporting (Composite), and Financial Health (Composite). The company must be covered by at least 2 of these 3 ratings for the calculation to be performed. We recommend that you carefully review the associated descriptions.
