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Global IVD: Made in USA

Your FDA-registered, ISO 13485:2016 certified partner for U.S. manufacturing

Your Why Choose Calbiotech?

For over 25 years, Calbiotech has specialized in the design, development, and manufacturing of in vitro diagnostics (IVDs). As an FDA-registered and ISO 13485:2016 certified manufacturer, we combine regulatory expertise with deep technical know-how across multiple IVD modalities — including ELISA, CLIA, rapid tests, molecular assays, and custom reagent formulations.Our U.S. location provides global partners with more than just production capacity — it’s a gateway into the U.S. healthcare market with the quality and compliance standards required to succeed.

Manufacturing Services

We provide full-spectrum IVD manufacturing tailored to the needs of international diagnostic companies:

Contract Manufacturing

ELISA, CLIA, lateral flow, molecular formats.

Reagent Production

Buffers, conjugates, antigens, antibodies, and master mixes.

Fill–Finish & Lyophilization

High-precision filling and stabilization for global shipping.

Regulatory & Technical Transfer Support

Seamless transfer of technology under U.S. FDA and ISO quality systems.

The U.S. Advantage

For international IVD companies, U.S.-based manufacturing is a strategic asset.

  • Market Access

    Manufacture closer to your end-customers and distributors to eliminate fulfillment challenges.

  • Regulatory Alignment

    Products made under FDA and ISO standards build instant credibility with customers.

  • Risk Diversification

    Reduce exposure to global trade uncertainty by adding a U.S. production base.

  • Speed & Reliability

    Faster logistics, fewer customs hurdles, and improved supply chain resilience.

Case Study: Protecting Margins With U.S. Manufacturing

One of our global IVD partners, headquartered in Europe, was thriving in the U.S. market — until new tariffs began eroding profitability. Import duties drove costs up, margins down, and threatened the sustainability of their growth strategy.To address this, they moved production of a key diagnostic product from their European facility to Calbiotech’s U.S. site. Our team completed the full technology transfer and validation in just three months, ensuring uninterrupted supply to their U.S. customers.The impact was significant: over $500,000 in annual savings from tariffs alone. On top of that, the client realized reduced logistical costs and overall process decosting, further strengthening their profitability and competitiveness in the U.S. market.

Our Proven Path to U.S. Manufacturing Success

At Calbiotech, we’ve built long-standing partnerships with some of the world’s leading IVD and pharmaceutical companies who rely on us as their U.S. manufacturing base. With decades of technical expertise, FDA registration, and ISO 13485:2016 certification, we provide the confidence, compliance, and scalability required to bring international products successfully into the U.S. market. Our process is straightforward and efficient, focusing on quality, cost-optimization and speed to market.

Every successful project begins with a clear understanding of your goals. We start by aligning with your team to define the assay, market entry strategy, and regulatory pathway for the U.S. Our scientists and project managers work with you to identify technical requirements, production volumes, and commercialization timelines, ensuring that your U.S. launch strategy is realistic and achievable.

Our dedicated tech transfer process ensures that your assay is seamlessly adapted into Calbiotech’s FDA-registered and ISO 13485:2016 certified quality system. Whether you are transferring from a European manufacturing site, a university lab, or a pilot facility, we capture your specifications and SOPs, validate critical steps, and integrate them into our production workflows. This reduces downtime and safeguards the integrity of your assay during the transition.

With decades of experience in ELISA, CLIA, molecular, and rapid test manufacturing, we bring your product into full-scale production under rigorous quality control. Our facilities are equipped for batch-to-batch consistency, precision reagent preparation, kit assembly, and final QC release. Each run undergoes strict in-process monitoring and validation to meet U.S. regulatory and customer standards.

As your market presence grows, so does our support. We can rapidly expand capacity to meet increasing demand, offering flexible production volumes from pilot batches to large-scale commercial runs. With our San Diego location, we simplify logistics for U.S. customers, reducing shipping times, customs delays, and supply chain risks. Whether serving regional distributors or nationwide networks, we ensure your assays reach the market quickly and reliably.

Our partnership doesn’t stop at production. We provide continuous support with regulatory updates, technical troubleshooting, and process optimization. From reformulation for stability improvements to guidance on FDA submissions and distributor onboarding, our team acts as an extension of yours. This long-term collaboration ensures your U.S. operations remain efficient, compliant, and competitive.

Protect Profits. Ensure Stability.

Calbiotech helps global IVD and pharma leaders protect margins and ensure supply with U.S.-based manufacturing.

Start Manufacturing in the U.S.