Customized in-vitro diagnostic consumable - Stevanato Group
Stevanato Group is specialized in the development and manufacture of customized in-vitro diagnostic consumable including molecular diagnostic, laboratory and point-of-care use.
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Developing and manufacturing complex IVD consumables tailored to your needs

We specialize in the development and manufacture of tailor-made consumables for in-vitro diagnostics including molecular diagnostic, laboratory and point-of-care use.  Our core capabilities in scientific research and development, together with our commitment to technical innovation, allow us to offer value-added solutions including integrated diagnostic or microfluidic lab-on-chip functionalities.

Our team of experts in R&D, industrialization, molding, manual and automatic assembly, quality and regulatory support make us your ideal partner for customized diagnostic consumable solutions.

We assist you throughout the product life cycle from concept development, product design, and process optimization to industrialization and beyond. Customers rely on us for efficient project management and 360° support – leading to longstanding relationships. Moreover, our 24/7 manufacturing in controlled areas and cleanrooms meets the highest quality standards, including IVDR, to ensure best-in-class solutions.

Our modular CDMO approach for diagnostic and laboratory products enables flexible entry at various stages, depending on your project status.

Different Needs, Different Customer-specific Solutions

Diagnostic Consumables

Diagnostic consumables require stable, replicable production at high volumes. We are experienced in manufacturing thin-wall PCR plates, including microfluidic channels, and single and multi-chamber cuvettes for optical analysis, plus tips and cups to perform a multitude of different immunological tests.

Laboratory and PoC Consumables

Laboratory devices and PoCT consumables produced applying scientific molding methodologies. Fully automatically assembled, including sealing functions, mechanical operations, camera inspection. They can be offered free from human DNA for molecular and immunodiagnostic.

Case Study

The Challenge

Our European-based customer was looking for high-quality cartridges holding reagents and single-use reaction modules (cuvettes) to perform the assay for his fully automatic laboratory. High functionality and tightness are of the essence to guarantee high-quality and highly efficient solutions, as well as overall system flexibility and this is what Stevanato Group was exactly able to offer.

Our Added Value

  • The Cartridge development we carried out as CDMO was done in close cooperation with the customer based on their analyzer systems requirements.
  • Production of all plastic parts was made on our high-precision molding equipment.
  • We carried out the fully automatic assembly via a modular system, including ultrasonic welding steps, cutting and exact positioning of membranes, and integrating movable parts.
  • Functionality test and visual camera inspection of the assembled product.
  • Attachment of labels, including printing of batch-specific data and read-out test.
  • Full project responsibility and regulatory support for subsequent approvals to deliver 360° assistance to our customer.
Interested in In-Vitro Diagnostics Consumables?
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