A Distant Dream
India’s laboratory infrastructure requires regulation and standardization to make it safe for billions of patients
Rohit Jain | | Opinion
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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