Introduction to in vitro diagnostic reagents, how many are the classifications of in vitro diagnosti

The difference between biological reagents and diagnostic reagents: biological reagents refer to biological materials or organic compounds related to life science research, as well as reagents used in clinical diagnosis and medical research. Diagnostic reagents are divided into two categories: in vivo diagnostic reagents and in vitro diagnostic reagents.

Generally, it refers to products, such as some first-class detection, blood group testing, lipid testing, cytokine testing, etc., which are mostly used for some disease detection or food safety testing. Shanghai Jizhi Biochemical Technology Co., Ltd. is a comprehensive reagent company dedicated to the R&D and sales of biochemical reagents and products in the field of life sciences. Headquartered in Shanghai, China, and in Shanghai, Hebei has a large logistics warehouse, the number of goods up to 40,000 kinds, the adoption of modern warehousing advanced logistics system, to ensure the safe, rapid and timely delivery of reagents to customers.

The in vitro diagnostic reagents referred to in the Administrative Measures for the Registration of In Vitro Diagnostic Reagents (Trial) refer to the in vitro diagnostic reagents managed by medical devices, including reagents, kits, calibrators (objects), quality controls (objects), etc., which can be used alone or in combination with instruments, appliances, equipment or systems for in the process of disease prevention, diagnosis, monitoring, prognosis observation, health status evaluation and hereditary diseases.

The in vitro diagnostic reagents used by the state for blood screening and in vitro diagnostic reagents labeled with radionuclides do not fall within the scope of the Administrative Measures for the Registration of In Vitro Diagnostic Reagents (Trial).

In vitro diagnostic reagent business enterprises must engage in business activities in accordance with the "Good Manufacturing Standards for Pharmaceutical Operations".

According to the degree of risk of the product, in vitro diagnostic reagents are divided into the third category, the second category, and the first category of products.

Question 1: What are the in vitro diagnostic reagents In vitro diagnostic reagents are divided into two categories:

The first category is managed in accordance with medical devices, including reagents, kits, calibrators (objects), quality controls (objects), etc., which can be used alone or in combination with instruments, appliances, equipment or systems for in the process of disease prevention, diagnosis, monitoring, prognosis observation, health status evaluation and hereditary diseases.

The other category is managed by drugs, including in vitro diagnostic reagents for blood screening and in vitro diagnostic reagents labeled with radionuclides.

Question 2: What is in vitro diagnostic reagent According to the "Administrative Measures for the Registration of In Vitro Diagnostic Reagents", in vitro diagnostic reagents refer to reagents, kits, calibrators, quality controls and other products used for in vitro detection of human samples in the process of disease prevention, diagnosis, detection, prognosis observation and health status evaluation.

Question 3: Which category does in vitro diagnostic reagents belong to That is, the IVD industry still belongs to the medical device industry, but it needs to register a business license for in vitro diagnostic reagents within the scope of business.

Question 4: What are the companies that produce in vitro diagnostic reagents Abroad: Roche, Abbott, Johnson & Johnson, Bayer, Pfizer (09 $68 billion acquisition of Wyeth), Omon.

Domestic: Shanghai Kehua (the first in China.

1. Listing), Zhongshan Da'an (main molecular diagnostic reagents, listed), Zhongsheng Beikong (strong biochemical reagents), Yingke Xinchuang (wholly owned by the United States), Beijing Wantai, Shanghai Rongsheng, Fosun Diagnostics, etc.

There are: Maccura Biotech (****:300463), Dongfang Biotech (****:

688298), MeCan Biotechnology (****:300439), Shuoshi Biotechnology (****:688399), New Open Source (****:

300109) and so on. Not sure.

Sichuan Maccura Biotechnology Co., Ltd. is one of the largest R&D and production enterprises of clinical in vitro diagnostic reagents in China. In October 1994, Sichuan Mike Technology Co., Ltd. was established, and in December 2009, it was officially renamed and established as Sichuan Mike Biotechnology Co., Ltd.

Shijiazhuang Oriental Biotechnology Co., Ltd. was founded in 1970 as a local collective enterprise, and was restructured into a private joint-stock company in 2000. The company covers an area of 25,000 square meters, with 200 employees, including 56 middle and senior scientific and technological personnel, with its own laboratory, laboratory and advanced measurement and testing instruments, and cooperates with scientific research institutions to develop new products.

MeCan Group is a high-tech enterprise with investment in high-tech biotechnology research and development, product production and sales as its core industry, with five holding subsidiaries. The Group focuses on the prevention and diagnosis of human health, and the R&D and utilization of microorganisms as its main research and development directions.