First, according to the drug management in vitro biological diagnostic reagents include:
1. Blood type and tissue matching reagents (such as anti-A and anti-B standard serum used by blood bank to identify ABO blood type; Anti-d serum used to identify Rh blood group, etc. )
2. Microbial antigens, antibodies and nucleic acid detection reagents (such as enzyme-linked immunosorbent assay (ELISA) and gold standard test kit for detecting hepatitis B, hepatitis C, AIDS and syphilis; PCR, etc. )
3. Tumor marker reagents (such as AFP and CEA). )
4. Immunohistochemistry and Human Tissue Cell Reagents
5. Human gene detection reagent
6. Biochemistry
7. Allergy diagnostic reagents
Two, according to the management of medical devices in vitro diagnostic reagents include:
1. Clinical basic test reagents (such as blood cell analyzer matching reagents, urine machine urine strip, early pregnancy test paper, occult blood and other commonly used clinical reagents, etc. )
2. Clinical chemical reagents (such as airborne or manual biochemical reagents used in biochemical room)
3. Blood gas and electrolyte determination reagents
4. Vitamin determination reagent
5. Cytohistochemical dyes
6. Autoimmune diagnostic reagents
7. Microbial test reagents
In addition, in order to understand the legitimacy of suppliers, suppliers are required to provide the following qualification documents:
(a) the supplier's medical device business license (pay attention to check the allowed business scope of several types of devices)
(two) the supplier's drug business license (pay attention to check whether there are diagnostic drugs)
(3) the business license of the supplier
(four) the medical device or drug production license of the product manufacturer (diagnostic reagents belonging to medical devices must have a medical device production license; Diagnostic drugs that belong to diagnostic drugs must have a drug production license. )
(5) The production approval number of the product provided (if it belongs to Class III medical devices, it must be the State Food and Drug Administration (standard)? Number; What is the word (quasi) (or) of the provincial and municipal food and drug administrations approved by the food and drug administrations of all provinces and municipalities directly under the Central Government for medical devices of Class I and Class II? Font size; If it is an imported product, an import registration certificate must be provided; If it belongs to drugs, it must be the national food and drug (quasi-) name.
(six) the power of attorney of the manufacturer of the supplied products to the supplier.
(seven) the power of attorney from the supplier to the sales staff. Copies of the above documents shall be stamped with the new seal of the supplier.