Accelerate Your In-Vitro Diagnostics (IVD) Device Production
End-to-End Assembly, Kitting, Packaging, and Sterilization Services
In-Vitro Diagnostics Device Expertise
In-vitro diagnostics (IVD) devices play a critical role in patient care, requiring precision manufacturing, rigorous quality control, and full regulatory compliance. With evolving FDA and ISO regulations, IVD manufacturers must ensure product accuracy, sterility, and consistency—while optimizing time-to-market.
LSO partners with leading and emerging IVD OEMs to provide scalable, compliant, and cost-effective solutions for diagnostic device assembly, kitting, packaging, and sterilization. Our integrated services help manufacturers accelerate production while maintaining the highest standards of quality and regulatory compliance.
In-Vitro Diagnostics Device Capabilities
Life Science Outsourcing provides specialized expertise in the manufacturing, packaging, and sterilization of IVD devices.
Cleaning & Decontamination
We deliver precision cleaning and decontamination to ensure diagnostic devices meet sterility, safety, and regulatory requirements.
Cleanroom Assembly & Kitting
From lateral flow test kits to reagent handling, LSO offers turnkey cleanroom manufacturing and kitting solutions tailored to IVD products.
Labeling
Our in-house labeling capabilities ensure compliance with FDA, ISO, and UDI (Unique Device Identification) regulations while maintaining high-quality standards.
Sterilization
LSO provides contract sterilization and validation services to meet the strict requirements for single-use and reusable IVD components.
Product Portfolio
- Point-of-care (POC) diagnostic devices
- Lateral flow assay kits
- Blood glucose meters and test strips
- PCR and molecular diagnostic devices
- Microfluidic diagnostic cartridges
- Lab-on-a-chip devices
- Reagent handling and dispensing systems
Why LSO?
Specialized Expertise for In-Vitro Diagnostics OEMs
IVD devices require absolute precision, sterility, and compliance to ensure accurate diagnostic results and regulatory success. LSO’s integrated solutions help manufacturers streamline production while meeting the highest quality standards.
- Faster Time-to-Market
Accelerate product development and commercialization with seamless cleanroom assembly, kitting, and sterilization services. - Regulatory & Compliance Expertise
Navigate complex FDA, ISO 13485, and CLIA (Clinical Laboratory Improvement Amendments) regulations with our quality-driven approach. - Cost-Effective, Scalable Solutions
Optimize costs with fully integrated in-house services designed for everything from prototype development to large-scale production. - End-to-End Manufacturing & Sterilization Expertise
From diagnostic kit assembly and packaging to validated sterilization, we provide a one-stop solution for IVD manufacturers.
