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Outside the Lab Regulation and standards, Quality assurance and quality control, Point of care testing, Laboratory management

A Distant Dream

What exactly is an in vitro diagnostic medical device (IVD)? It’s the instrumentation needed to carry out a particular pathology test (or tests) on human samples to assist in clinical diagnosis or treatment decision-making. These devices include the laboratory or point-of-care devices, calibrators, controls, kits, reagents, and accessories used to perform diagnostic tests. IVDs are distinct from medical devices in that they never come into direct contact with the patient; however, they still have an impact on life-changing, and potentially life-saving, treatment decisions.

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About the Author

Rohit Jain

Consultant Pathologist at Santokba Durlabhji Memorial Hospital and Founder Secretary of the Practicing Pathologists Society, Jaipur, Rajasthan, India.

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