
2018-12-18
Small
0personInquired
0personFavorited
ConnectType:
T - Technology & Patents
Industry:
Fine Chemical Manufacturing
Country / Region:
China
Company Type:
OtherListed companySpecialized refined distinctive and innovative enterprises
Registered Capital:
100 million RMB
Company Capability: Process Technology Development、Chemical Technology & Patents、Technology Transfer、Process Package Design
UP Biotechnology (Hubei) Co., Ltd. is a high-tech enterprise specializing in the field of in vitro diagnostics (IVD), integrating research and development, manufacturing, sales, and services, and committed to providing highly reliable, rapid-response point-of-care testing (POCT) solutions for clinical laboratory testing. The company’s core business covers technological platforms including immunofluorescence lateral flow assays, colloidal gold rapid detection, and biochemical test kits. Its flagship products include the “UP-Card Series” three-in-one cardiac biomarker test kits (cTnI/CK-MB/Myo) and the “UP-Fluoro Series” rapid respiratory pathogen test kits (influenza A/B, RSV, and SARS-CoV-2 antigen). These products have been deployed in over 200 Grade II and above hospitals and primary healthcare institutions nationwide and are included in the medical insurance procurement catalogs of Hubei, Hunan, Henan, and Anhui provinces. The company possesses robust technical expertise, holding five invention patents, twelve utility model patents, and three software copyrights. Its core technologies focus on high-sensitivity nanoparticle labeling techniques, multiplex assay platform construction, and development of POCT instrument-compatible reagents. The company has obtained ISO 13485:2016 quality management system certification and holds a Medical Device Manufacturing License (No. ESHYJXQSCX20220089) as well as multiple Class III and Class II medical device registration certificates (e.g., ESHXZZ20222401237). Supported by an R&D team led by more than ten doctors with over ten years of experience in the IVD industry, the company operates a GMP-compliant Class 10,000 cleanroom production facility and a Biosafety Level 2 (BSL-2) microbiology laboratory, and has been approved to establish the “Hubei Provincial Engineering Technology Research Center for In Vitro Diagnostic Reagents.” The company continuously conducts clinical validation studies and academic collaborations—for instance, jointly completing a multicenter clinical evaluation of an early-warning assay for acute heart failure with Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Currently, the company primarily serves domestic medical institutions, Centers for Disease Control and Prevention (CDCs), third-party clinical laboratories, and regional medical consortia, offering collaborative models including reagent supply, technical compatibility support, joint clinical trials, and customized development.
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