Hematology in-vitro diagnostics are important parts of IVD market
In Vitro Diagnostics (IVD) are very different from other medical devices – they do not come in direct contact with patient, value of the knowledge and information they deliver and no therapeutic effect claimed. IVD products include not only the instruments, systems, and reagents used to perform the tests, but also the products intended for use in the collection, preparation, and examination of specimens taken from the human body. And these IVD medical devices are categorised into three classes by FDA, Class I – low-risk medical devices, Class II intermediate risk medical devices and class III high.
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