What Are Diagnostic Reagents?
Diagnostic reagents are used to diagnose a range of health issues by screening for pathogens, antigens, co-infections, genetic diseases, and a host of other physical diseases.
They can be used either in vivo or in vitro, and are most commonly known today as the key player in rapid diagnostic tests (RDT) for COVID-19.
ReAgent has been providing diagnostic reagent services in the UK for almost 50 years.This means we know how to create efficient, accurate reagents for this purpose.
Types of Diagnostic Reagents
IVD reagents
Good healthcare depends on the biological and clinical analysis of samples that provide consistently accurate diagnoses. Most of the medical devices that perform these analyses require in vitro diagnostic (IVD) reagents to deliver accurate results, enabling healthcare providers to dispense targeted treatment plans.
Medic diagnostic reagents
Medic diagnostic reagents are a vital part of medicine. 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 producing the results run continuously to meet service demand, so consistent reliability and accuracy of analysis is important.
Ancillary reagents
Ancillary materials (AMs) are reagents used in the manufacture of cell therapy products. Even though they are not present in the final product formulation, they are still crucial to ensuring the critical quality attributes of the end product.
Our Diagnostic Reagent Services
As a leading diagnostic reagents supplier, we have in-depth experience in manufacturing a range of high-quality reagents, including:
IVD reagents
ReAgent manufactures IVD reagents under strict quality controls, using chemicals approved for their specific purposes. Sterile packaging, ISO Class 7 cleanroom conditions, and options for short shelf-life products ensure reliability. Cold and frozen storage solutions prevent product degradation during transit.
Medic diagnostic reagents
Our ISO 13485 accreditation enables us to produce medical reagents tailored to customer specifications. We specialise in manufacturing testing solutions, ensuring compliance with stringent life sciences and diagnostics industry standards.
Ancillary reagents
Our ancillary reagent range includes consumables for immunohistochemistry (IHC) and in situ hybridisation (ISH), such as epitope retrieval solutions and wash buffers. Each product undergoes rigorous analysis and fine filtration to eliminate contamination.
Peace of Mind with ISO 13485 Accreditation
Our ISO 13485 certification ensures compliance with stringent quality management standards surrounding medical devices. This provides:
- Assurance of clinical-grade manufacturing processes
- More time to focus on developing your diagnostic reagents
- Confidence in product quality for end-users
Credibility and reliability as your manufacturing partner
ReAgent’s High Quality Standards
We manufacture our clinical diagnostic reagents and biological buffers in our state-of-the-art facility in Cheshire, UK. This is so that we can ensure our products meet the stringent requirements of all out ISO accreditations, including:
- ISO 13485 – Quality management specific to medical devices, meeting regulatory and directive requirements.
- ISO 9001 – Guarantees high manufacturing standards and continuous improvement.
- ISO 14001 – Demonstrates commitment to sustainability and reduced environmental impact.
- ISO 45001 – Reflects dedication to occupational health and safety.
We employ LEAN principles to optimise efficiency, expand services, and meet your delivery and inventory management needs.
ISO 9001 Quality Standard
ISO 13485 Medical Devices
ISO 14001 Environmental Standard
ISO 45001 OHS Standard
Ready to discuss your requirements?
Call our technical sales team on 0800 9555 798
Working Together With Our Expert Team
As a customer-led business, we can be flexible and adapt to meet your requirements for reagents, no matter the type. This could mean developing new manufacturing techniques, investing in new equipment, or undertaking training for your needs.
If you need us to adopt industry-specific systems to meet the necessary standards, we are happy to do so.
Our expert technical team will also provide their advice and expertise every step of the way. 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.
New Product Development
In our diagnostic reagent manufacturing process, our products are tailored to markets including (but certainly not limited to):
- Medical devices
- Industrial markets
- Leisure markets
- Institutional markets
- Laboratory equipment
Our in-house chemists and technicians develop cost-effective, high-performance solutions tailored to your market and specific needs.
Custom Product Development
- Free pre- and post-sales support
- Testing for consistent high quality
- Full regulatory compliance
Why Choose ReAgent as Your Diagnostic Reagents Supplier?
Face-to-Face Support
Our door is open for audits, technical discussions, or collaborative planning.
Full Batch Traceability
Every batch is fully traceable through our bespoke in-house system.
End-to-End Service
We manufacture, label, and deliver products directly to you or your customers, ensuring a seamless process.
Diagnostic Reagents FAQs
We offer medic diagnostic reagents, IVD reagents, and ancillary reagents.
Yes, we provide Certificates of Analysis.
You can find all our safety data sheets for our off-the-shelf chemicals here.
Please call our friendly team on 0800 9555 798 or request a quote here to get started.
We offer bulk purchase and bulk pricing discounts. Please get in contact to learn more.
Please call our friendly team on 0800 9555 798 or request a quote here to get started.
We can ship by road, rail, and sea, as well as internationally. Manufacturing lead times will depend on the size of the shipment, and delivery times will depend on the final destination. We can provide an estimated lead time upon receipt of your enquiry.
You can apply for a 30-day credit account, or pay by credit card or bank transfer.
If you need an order urgently, please call our team on 0800 9555 798 and we will be happy to help.
Please call our team on 0800 9555 798 to speak to someone about your order.
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