Full-scale cGMP and ISO 13485 compliant manufacturing services for in vitro diagnostic products. Supports formulation, fill, finish, and distribution from concept to commercial scale.
Manufactured by
Bio-Techne Diagnostics
Minneapolis, MN, United States
Bio-Techne is a proven leader in clinical diagnostics with more than 40 years history manufacturing in vitro diagnostic products. We complement your in house expertise with a full breadth of products and services to successfully bring projects to market. Bio-Techne Diagnostics offers a comprehensive family of quality controls, calibrators, calibration verifiers, proficiency testing materials and assay development, diagnostic reagents available in various formats including liquid, lyophilized, powder and tablets. As an industry leader, we also supply bulk purified proteins, enzymes, disease-state plasmas, infectious disease antigens, veterinary diagnostics and processed serums to the clinical diagnostic industry.
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FlexMedical Solutions Ltd. · United Kingdom
Full manufacturing services for diagnostic devices including production control, validation, and quality assurance under ISO13485 standards.
Quaero Life Science Co.,Ltd. · China
Contract development and manufacturing services for IVD instruments and consumables, providing end-to-end solutions from design to production. Operates multiple GMP-certified manufacturing facilities across Asia and North America. Supports clinical diagnostics companies with scalable, validated manufacturing processes.
Randox Laboratories Ltd. · United Kingdom
Contract manufacturing services for in vitro diagnostic reagents and testing products. These services support development and production of diagnostic solutions for clinical use.
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