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Source: Chinese In Vitro Diagnostic Network CAIVD
Recently, the State Administration of Food and Drug Administration has made some adjustments to the subdirectory of 6840 In Vitro Diagnostic Reagents Classification (2013 Edition). The catalogue gives a detailed classification of in vitro diagnostic reagents and an overview of 766 product categories, classification names, intended USES and management categories. For the convenience of the industry, the latest classification is as follows: Supplement: III-8 allergen-related reagents: IgE detection reagents, specific IgE antibody detection reagents, as the second type of medical device management.
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