Clinical chemistry reagents and kits are considered in-vitro diagnostic devices (IVDs) per CDSCO guidelines. They are regulated by the Medical Device Rules, 2017. To manufacture or import clinical chemistry reagents and kits, you need to comply with CDSCO...
In-vitro diagnostic devices (IVDs) are instruments, reagents, or systems used to diagnose a disease or other health conditions. IVD tests are usually performed in test tubes or other similar equipment outside the body. Moreover, the tests can be performed using...
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