What are in vitro diagnostic 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 (IVD) 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 in vitro diagnostic reagents can therefore assist in reducing costs incurred through equipment downtime and improve service demand.
Quality assurance with ISO 13485 accreditation
ReAgent is accredited to ISO 13485 (Medical devices – Quality management systems – Requirements), demonstrating that we adhere to the stringent 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 IVD reagents we supply for medical devices.
Our customers benefit from this accreditation with:
- Peace of mind that we have manufacturing processes and controls suitable for chemical products used in medical devices
- More time to focus on the bespoke IVD reagent you need, rather than on systems and processes
- The ability to provide confidence and quality assurance to the end user
- The immediate understanding that ReAgent is a credible, trustworthy manufacturer of bespoke IVD reagents
Bespoke IVD reagents
We develop and manufacture bespoke IVD chemical reagents for use with medical devices and in vitro diagnostic medical devices. As a customer-led business, you’ll find us flexible and adaptable to the needs of the medical device industry, whether that means investing in new equipment, undertaking additional training or implementing new processes.
Whatever your requirements, we’ll work collaboratively together to manufacture the IVD reagent you require, in the quantity you require, when you require it. You’ll have our technical team on hand to provide their advice and expertise. This team-based approach and ability to flex and adapt are two of the reasons ReAgent has a strong reputation as a high-quality chemical manufacturer and distributor in the UK. We become a manufacturing addition to your team, rather than just your chemical supplier.