How are in vitro diagnostic reagents classified?
2020-07-25
In vitro diagnostic reagents are classified into Class I, Class II, and Class III products according to their risk level, from low to high.
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2020-07-25
According to the current "Medical Device Supervision and Administration Regulations", medical devices refer to instruments, equipment, apparatus, in-vitro diagnostic reagents and calibrators, materials, and other similar or related articles used directly or indirectly on the human body, including the necessary computer software.
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