Company Name
Shanghai Bioyuan Biotech Co.,Ltd.
Company Introduction
Bioyuan is a leading provider of third-party quality control solutions, integrating R&D, manufacturing, and professional services to elevatediagnostic accuracy for laboratories worldwide.
We operate one of Asia’ slargest QC innovation centers-a GMP-certified facility with automated production lines, Producing millions of QC
products annually, we ensure consistency,reliability, and compliance with the highest laboratory standards.
Our portfolio covers 400+ analytes across Immunology, Clinical Chemistry, Hematology, Coagulation, and Molecular Diagnostics, Withproprietary technologies, Bioyuan QC products deliver exceptional accuracy,stability, and human-matrix compatibility across majorinstrument platforms.
Beyond QC products, Bioyuan offers end-to-end quality solutions, including intelligent QC soffware, professional QC training, and ISo15189:2022 consulting. Trusted by 5,000+ hospitals across China, we are recognized as a market leader and strategic partner to nationalclinical laboratory committees – with a strong record of supporting 70+ hospitals in achieving the IS0 accreditations.
Size (number of persons)
100-150
Official website
www.bioyuan.com
Contact person
Zhaozhen CAO
Contact email
caozhaozhen@bioyuan.cn
Product Name
1、Quality Controls
Product Introduction + Highlights
BIOYUAN is an independent QC manufacturer providing unbiased, reliable third-party controls to support clinical laboratories in error detection and compliance with ISO 15189:2022.
Our human-based, commutable matrix materials closely mimic patient samples, ensuring accurate reflection of assay performance. Consolidated multi-analyte controls improve laboratory efficiency and reduce operational costs. Extended shelf life enhances stability during transportation and minimizes the need for crossover studies.
We maintain high lot-to-lot consistency to reduce variability and risk, while offering clinically relevant levels that cover cut-off, analytical, pathological, and clinical decision ranges.
In addition, BIOYUAN integrates its QC products with the advanced BiO-LAN 2.0 intelligent data management system, providing comprehensive data recording, statistical analysis, Westgard rule management, charting, and customizable modules for enhanced laboratory quality management.
Can the products be experienced on-site?
NO
Are the products certified in Thailand and Malaysia?
YES
Is the product leading in the industry?
YES
Have the products been exported to Europe, America or other countries?
YES
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