In vitro test reagents, called in vitro diagnostic reagents, according to the "Food and Drug Administration on the issuance of in vitro diagnostic reagents classified subdirectory of the notice (Food and Drug Administration, mechanical control [2013] No. 242) document, according to the degree of risk, in vitro diagnostic reagents are divided into three classes, two classes, a class of products.
Four, the catalog "intended use" of the contents of the human body samples, if the sample refers to cerebrospinal fluid, urine, gastric fluid, etc., it is clearly written for the corresponding samples; if used for a variety of samples for testing, it is expressed as "used for the detection of human body samples ".
Fifth, the test substance is the same but clinically used for different intended use of the product, and according to the "In Vitro Diagnostic Reagent Registration Management Measures (for trial implementation)" Article 13 of the provisions of the different management categories (eg, HCG, ferritin for the test substance of the product), in this catalog are listed in accordance with the different management categories.
Expanded InformationNotice of the Food and Drug Administration on the Issuance of Classification Sub-catalog of In Vitro Diagnostic Reagents (Food and Drug Administration Measures for the Administration of In Vitro Diagnostic Reagents (for Trial Implementation)) (2013) No. 242)
Seven, according to the provisions of Articles 12 and 13 of Measures for the Administration of Registration of In Vitro Diagnostic Reagents (for Trial Implementation), reagents related to the testing of narcotic drugs, psychotropic substances, or toxic medicines for medical treatment are managed under the The third category of product registration management. The scope of narcotic drugs, psychotropic drugs or toxic drugs for medical use is determined in accordance with the "Catalogue of Narcotic Drug Varieties (2007 Edition)", "Catalogue of Psychotropic Drugs (2007 Edition)", "Measures for the Administration of Toxic Drugs for Medical Purposes" for toxic drug varieties.
VIII. This catalog does not include calibration and quality control products. The categories of calibrators and quality control products used in conjunction with the second and third types of in vitro diagnostic reagents are the same as the categories of reagents; calibrators and quality control products used in conjunction with the first type of in vitro diagnostic reagents are managed according to the second type of products.
State Drug Administration official website - Food and Drug Administration Mechatronics 〔2013〕 No. 242 Annex