Products and Solutions
Our products cover various fields, including biochemistry, immunology, microbiology, coagulation, and POCT. We have systematic capabilities in the professional research and development of in vitro diagnostic equipment, reagents, calibrators, and quality control products.
Microbial series products
Biochemical analysis products
Immunoassay products
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Company News
2024-10-18
New Market, New Opportunity | Quark Biotech Debuts at HOSPITAL EXPO 2024!
About Us
Explore our story
Learn moreFounded in 1993, Zhejiang Quark Biotechnology Co., Ltd. has always adhered to the enterprise purpose of "dedicated precision medicine, benefiting thousands of households", focusing on the research and development, production and service of in vitro diagnostic products. Committed to the road of localizing equipment products, we work hard to develop into a domestic first-class comprehensive service provider of in vitro diagnostic reagents and instruments.
The company has steadily pursued its enterprise mission of "making health easier" for over 30 years in the in vitro diagnosis industry, and are a "high-tech enterprise" certified by relevant national departments. We now have several modern production lines in line with GMP requirements, including for medical instruments, biochemical reagents, immune reagents, and microbial reagents. In addition to high-level R&D bases in locations such as Shanghai, Keqiao, and Jiaxing, the company also has a postdoctoral workstation and a Zhejiang Province foreign experts workstation. We offer products across the fields of biochemistry, immunity, microbiology, blood coagulation, POCT and more, and our professional R&D and manufacturing capabilities span in vitro diagnostic equipment, reagents, calibration products and quality control products. We are a project of the national science and Technology innovation fund and a Zhejiang Province major science and technology special unit.
We adhere to the quality concept of "excellence, quality, victory", with a complete traceability system. We are a member of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) China and have successfully passed the national Ministry of Health inspection center’s GB/T 19001:2016 IDT IS0 9001:2015, GB/T42061:2022 IDT IS013485:2016 inter-laboratory quality system assessments every year. We obtained the CNAS Medical Reference Laboratory accreditation in 2020, and some of our products have obtained the system certificate issued by the Shanghai branch of SUD Certification Testing (China) Co., LTD.
Quality system
The company has passed the dual system quality certification of GB/T19001 and IS013485, as well as the National Health Inspection Center’s interlaboratory quality evaluation of every year. It has been recognized as an honest enterprise by the drug regulatory department for many years and has professional traceability capabilities.
Passed the dual system quality certification of GB/T19001 and IS013485 by Beijing National Medical Equipment Huaguang Certification Co., Ltd
Became a Chinese member of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)
Became a collaborating unit of the European Union Committee for Standardization (IRMM)
The company's reference laboratory obtained CNAS accreditation
The enterprise obtained CE certification for select products through TUV certification and officially entered the international market
All participants in the project have successfully passed RELA2023 and EQARL2023 verification