The test object is not necessarily the human body. Devices that test human secretions, blood, etc. are also medical devices.
Enzyme markers, biochemistry analyzers, hematology analyzers, and so on are all medical equipment for testing. All in accordance with the requirements of medical standards.
For the scope of medical equipment, you can go to the State Food and Drug Administration website.
/datasearch/face3/dir.html
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/datasearch/face3/base.jsp?tableId=27&tableName=TABLE27& amp;title=Imported Instruments&bcId=118103063506935484150101953610
Type "enzyme marker" in "Imported Instruments" in the above URL. The search yielded 19 results for imported enzyme markers.
The State Food and Drug Administration defines "Enzyme Labeling Instrument" in the following catalog, which belongs to Class II medical devices:
Medical Devices Classification
Code Code 6844 Clinical Laboratory Analyzers
Classification Number 6840-03.2
Classification Name Immunoassay System
Category name Immunoassay System
Category name Immunoassay System
Classification name Immunoassay system
Examples of product names Enzyme immunoassay instrument, semi-automatic enzyme labeling instrument, fluorescence microdetection system, specific protein analyzer, chemiluminescent assay instrument, fluorescence immunoassay analyzer,
Management category Class Ⅱ