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Ortho Clinical Diagnostics (now QuidelOrtho) is an in vitro diagnostics company that made products and diagnostic equipment for blood testing.Ortho served two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion ...
QuidelOrtho Corporation is an American manufacturer of diagnostic healthcare products that are sold worldwide. [3]On May 8, 2020 the U.S. Food and Drug Administration (FDA) issued to Quidel the first emergency use authorization (EUA) for a COVID-19 rapid antigen test, a new category of tests for use in the ongoing pandemic.
Clinical laboratory in a hospital setting showing several automated analysers. A medical laboratory or clinical laboratory is a laboratory where tests are conducted out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease. [ 1 ]
The primary use case for the CCD is to provide a snapshot in time containing the germane clinical, demographic, and administrative data for a specific patient. [8] Diagnostic Imaging Report - A Diagnostic Imaging Report (DIR) is a document that contains a consulting specialist's interpretation of image data. [9]
Common technical document summaries. Quality. Nonclinical study reports. Clinical study reports; A full table of contents could be quite large. There are two categories of modules: Regional module: 1 (different for each region; i.e., country) Common modules: 2–5 (common to all the regions) The CTD defines the content only of the common modules.
Where there is a health care facility with laboratories, tests are divided into either general tests or disease-specific tests for clinical laboratories, and disease-specific tests for blood screening laboratories. [5] For each group of tests, the EDL specifies the test's name, purpose, assay format and type of specimen. [6]
Ortho Clinical Diagnostics; Metadata. This file contains additional information, probably added from the digital camera or scanner used to create or digitize it.
Diagnostic design specification is a document indicating how the diagnostics will be implemented on upcoming/new products that will be developed by the company. [1] It describes the behavior of the diagnostics like how the test will execute, how the output messages are formatted, and how the final result is displayed (among others). [ 2 ]
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