What companies produce in vitro diagnostic reagents?

1, Daan Gene: the main PCR reagent supplier in China.

2. Ke Hua Biology: the promoter of large-scale commercialization of ELISA kits in China.

3. Lidman: High-end biochemical diagnostic reagent supplier.

4. Nine creatures: creating a precedent for technology export of IVD enterprises in China.

5. Wanfu Bio: the leading enterprise in POCT industry in China.

6. Medical laboratory overall solution service provider.

7. Kangmei Bio: One of the most complete suppliers in the field of biochemical diagnosis in China.

8. Sannuo Bio: ranks among the leading camps of global blood glucose meters.

9. Ke Hua Bio: the main supplier of AIDS diagnostic reagents abroad.

10, mike biological: one of the largest R&D enterprises in China.

1 1, Cape Bio: the main provider of nucleic acid molecular diagnostic products in China.

12, Yangpu Medical: a leading enterprise in the field of blood diagnosis in China.

13, Bohui Innovation: a leading enterprise in the field of trace element detection in China.

14, Yidan instrument: an enterprise specializing in blood cell analysis instruments.

15, Fosun Pharma: the leading enterprise of biochemical detection instruments in China.

16, basic egg biology: the latest listed enterprise in POCT field in China.

17, Aide Bio: a leading enterprise in molecular diagnosis of tumor precision medicine.

Expand knowledge:

Introduction of in vitro diagnostic reagents

In vitro diagnostic reagents referred to in the Administrative Measures for the Registration of in vitro diagnostic reagents (Trial) refer to in vitro diagnostic reagents managed by medical devices, including reagents, kits and systems that can be used alone or in combination with instruments, appliances, equipment or systems for in vitro detection of human samples (various body fluids, cells, tissue samples, etc.). ) disease prevention, diagnosis, treatment monitoring, prognosis observation, health status assessment and genetic disease prediction in the process.

Second, the classification of in vitro diagnostic reagents

According to the degree of product risk, in vitro diagnostic reagents are divided into category III, category II and category I..

(a) the third category of products:

1. reagents related to the detection of antigens, antibodies and nucleic acids of pathogenic pathogens;

2. Reagents related to blood type and tissue matching;

3. Reagents related to human genetic testing;

4. Reagents related to hereditary diseases;

5 reagents related to the detection of narcotic drugs, psychotropic drugs and toxic drugs for medical use;

6. Reagents related to the detection of therapeutic drug targets;

7. Reagents related to tumor marker detection;

8. Substances related to allergic reactions (allergens).

(2) Category II products: Except products that have been clearly classified into Category III and Category I, all others are Category II products, mainly including:

1. protein detection reagent;

2. Sugar detection reagent;

3. Hormone detection reagent;

4. Enzyme detection reagent;

5. Ester detection reagent;

6. Vitamin detection reagent;

7. Inorganic ion detection reagent;

8. Reagents for detecting drugs and drug metabolites;

9. Autoantibody detection reagent;

10. Microbial identification or drug sensitivity test reagent;

1 1. A reagent for detecting other physiological, biochemical or immune function indicators.

(3) Category I products: