Diagnostic kit producer - High-quality kit primer supplier

For diagnostic kit producer

Are you looking for a reliable supplier that can deliver high-quality oligonucleotides and plasmid DNA on time and in the correct quantity?

 

 

Speak to our expert

icon

Tailored solutions

Our team of experts will work with you to find the right approach for your specific needs. Your expectations are our challenge.

READ MORE
icon

Fast & reliable delivery

Work with a partner that understands your critical demands. We keep our promises in terms of delivery times.

READ MORE
icon

Best-in-class quality

Reap the benefits of the high-quality standards that we have established to not only fulfil our own demands in our kit production facility, but also to meet your needs.

READ MORE

DO ANY OF THESE SOUND FAMILIAR TO YOU?

Your challenges


  • Delivery timelines are unreliable disrupting production planning.
  • Product quality is inconsistent, with noticeable variation from batch to batch.
  • Your required dye and quencher combinations limit your choice of suppliers.
  • Contamination prevention practices do not meet your needs.
  • You struggle to find an OEM supplier capable of manufacturing and assembling complete kits.
  • You miss a partner who puts your priorities first and communicates clearly and proactively.

 

 

Plan your needs with us

Whether it’s large-volume reagents, high-quality plasmid DNA, or ready-to-sell kits, we deliver what you need — on time, every time, and without supply-chain stress.

Proven CE-IVD quality

Our best-in-class oligonucleotide quality supports a wide range of kit manufacturers, including numerous external partners as well as our own internal CE-IVD test kit manufacturing teams. To achieve exceptional purity and product integrity, we use different HPLC purification methods. End-product control by Reverse Phase and Ion Exchange UPLC and MALDI-TOF MS guarantees that only oligos of the highest quality leave our facilities.
Our plasmid preparations follow the same rigorous standards, making them the ideal choice for use as assay controls, reference materials, and other critical applications. As an ISO 13485-certified provider, we meet and exceed all relevant industry quality requirements.

Speed up your assay development

Start with small amounts of primers, probes, and plasmid DNA to test and validate your assays. Benefit from our express production that delivers small-scale oligos in under 24 hours. Larger scale oligos are available with turnaround times starting at 15 days. Turnaround times for plasmid preparations start from 5 days for smaller scales.

From bulk supply to customised OEM kits

We offer highly flexible and customised OEM solutions ranging from flasks containing your full annual oligonucleotide demand to smaller vials tailored to your specific lot sizes, or even pre-plated, ready-to-use dried reaction mixes. Looking for additional support? As an experienced OEM partner, we also provide tube filling with reaction mixes, as well as complete kit assembly, packaging, and shipping. Speak to us! Our experts are ready to discuss the details of your project requirements and support you every step of the way.

High flexibility on dye and quencher

Are you currently tied to a specific supplier, but interested in exploring more open-ended solutions? We offer license-free, non-proprietary dye and quencher combinations for qPCR probes and have experience working with many alternative dyes. Ask our team about our cost-effective solutions for commercial kits designed specifically for commercial kit manufacturers.

Stringent processing – plasmid DNA you can rely on

Your plasmid DNA is prepared with precision and strict contamination prevention practices, including single-use materials, separated laboratory with line clearance, and dedicated one-sample processing. These measures ensure maximum purity and full traceability throughout production. Whether you need expression plasmids, positive controls, or reference standards, we deliver high-quality plasmid DNA to ensure reliable and consistent kit performance. Get in touch with our team to discuss how we can adapt our plasmid preparation to suit your specific project needs.

Support for your IVD performance studies

As an independent laboratory with extensive experience with PCR methods and (clinical) performance validation, we can support your studies to help you achieve a fast CE-IVD approval for your diagnostic assay. Do you need to evaluate the reproducibility of your IVD performance? Require support with analytical or clinical performance validation? Looking to assess your assay against comparator methods? Contact us about your individual requirements! Our experts are ready to guide you through every step of the process.

Free consulting
100%

Our team of experts can advise and assist you with all the information on our diagnostics service offer 

 

Your dedicated Genomics Experts

MEET OUR TEAM

Ask us anything about genomics along your value chain — we’re happy to help.

Approved by your press

Eurofins Genomics is a trusted brand around the globe

icon

We cooperate with renowned organisations ranging from small-, medium- to large-scale enterprises

We provide leading expertise and technologies for the fast growing diagnostic market. We are not only a supplier for oligonucleotides, we also produce and deliver full test kits and have already performed millions of diagnostic SARS-Cov2 tests in our labs with our own test kits. We have built up a wealth of knowledge, which we would be delighted to share with you! Explore what we can do for companies in your industry.

LEARN MORE

QUALITY IS OUR MIDDLE NAME

Work with a fully certified partner

 

To ensure the high-quality of our oligonucleotides, Eurofins Genomics’ quality assurance is based on supply, process, product and performance control.

Our teams of highly-qualified experts and scientists in IT, chemistry and molecular biology continuously work to surpass your expectations of optimum oligos.

icon

ISO 13485 certification

  • ISO 13485 defines all general requirements for “Medical Devices – Quality Management Systems Requirements” for regulatory purposes.
  • It applies to manufacturing or assembly of medical devices (MD), of in vitro diagnostic products (IVD) and reagents or substances for use in IVD or MD.

 

Key requirements of ISO 134855

  • Documentation and validation of specialized processes
  • Full traceability of production processes
  • Focus on risk management activities during production and the provision of services
  • Change and deviation management
  • Monitoring of the working environment to ensure product safety

 

The compliance with ISO 13485 is certified by an approved certification body and independent internal audits.