We are a quality-accredited, flexible manufacturer of bespoke in vitro diagnostic (IVD) reagents for use with medical devices. The products we supply, primarily to the life sciences and molecular diagnostics industries, provide consistent, reliable results and meet stringent IVD requirements.
All the IVD reagents we manufacture use chemicals approved for their intended use, are subject to extensive quality checks, and we have full change control and notification processes in place.
We can also pack IVD reagents in sterile, DNAse and RNAse-free packaging, and manufacture them in ISO Class 7 cleanroom conditions. Products are routinely filtered to 0.2µ during the packing process. We are also able to produce and pack reagents which have a short shelf-life, as we have both cold and frozen storage available. That means we can store and transport products at the optimum temperature to prevent degradation of the product.
What Are IVD Reagents?
Good healthcare depends on the biological and clinical analysis of samples which provide consistently accurate diagnoses. Most of the medical devices which perform these analyses require in vitro diagnostic reagents to deliver accurate results, enabling healthcare providers to dispense targeted treatment plans. <
Why IVD Reagents Are So Important
The analysis of saliva, blood, tissue, and other bodily fluids provides doctors with the critical information they need to give a medical diagnosis. It’s often the case that the medical devices which produce the results run continuously to meet service demand, so consistent reliability and accuracy of analysis is crucially important.
The efficient, high-quality manufacture, handling, and delivery of IVD reagents can therefore assist in reducing costs incurred through equipment downtime and improve service demand.
At ReAgent, we have in-depth experience in manufacturing high-quality ancillary reagents for use in the manufacture of cell therapy products. The ancillary reagents we produce include instrument consumables for immunohistochemistry (IHC) and in situ hybridization (ISH). We manufacture epitope retrieval solutions, pre-treatments, detection components, and wash buffers for either manual and automated use.
As a customer-led business, we can be flexible and adapt to meet your requirements for ancillary reagents. This could mean we develop new manufacturing techniques, invest in new equipment, or undertake training. If you need us to adopt industry-specific systems to meet the necessary standards, we are happy to do so.
COVID-19 Testing Reagents
We are currently manufacturing and supplying buffers and reagents for use in different types of coronavirus test kits, including lateral flow test kits and LAMP tests. We have the capacity, expertise, and flexibility to manufacture enough solutions for tens of millions of tests per week, supplied in drums or IBCs.
To talk to a specialist in buffers for COVID-19 test kits, please call us on 1-800-817-175.
Peace of Mind with ISO 13485 Accreditation
ReAgent is accredited to ISO 13485, and we adhere to the strict requirements of a quality management system specific to the medical devices industry. We meet the current Medical Device Directives, regulations, and responsibilities, and are committed to the safety and quality of the diagnostic reagents we supply.
You can benefit from this accreditation with:
- Peace of mind that we have manufacturing processes and controls suitable for diagnostic reagents used in medical devices
- More time to focus on the bespoke diagnostic reagent you need, rather than on systems and processes
- The ability to provide confidence and quality assurance to your end user
- The knowledge that ReAgent is a credible, trustworthy manufacturer of bespoke diagnostic reagents
Our High Quality Standards
Our raw materials are sourced from around the world, but we manufacture our diagnostic reagents and biological buffers in our state-of-the-art facility in Cheshire, UK. This is so we can ensure our products meet the stringent ISO 9001:2008 Quality Standard and our ISO 14001:2004 Environmental Standard, as well as ISO 13485. It also means we’re able to manufacture your products as quickly as possible, and provide better value for money.
We also employ LEAN manufacturing principles and continually look to improve. We use the most efficient techniques available, can expand our services to meet your requirements, and ensure on-time delivery. We also provide end-to-end support, from pre-sales technical advice to managing inventory and the supply chain.
Whatever your requirements, we’ll work closely with you to supply the diagnostic reagent you need, in the quantity you need, when you need it. Our expert technical team will provide their advice and expertise whenever you need it. This team approach and our ability to adapt are just a couple of reasons why we have an outstanding reputation as a high-quality chemical and contract manufacturer.