In vitro Diagnostics

Quality healthcare products

Northern Ireland Protocol

Placing your business at the centre of all markets

Contract Manufacturing

Bespoke manufacturing solutions

Prestige – In Vitro Diagnostics

Prestige Diagnostics are In-Vitro Diagnostics & Point of Care Diabetes specialists. We are located in Ballymena in Northern Ireland – giving us unique access to the UK, European single market & global distribution channels beyond.

POCT Diabetes & In Vitro Diagnostics (IVD) Testing

Please contact us today for more information.

Covid 19 Test Kits, Analysers & Reagents

We manufacture a range of well over 100 IVD Reagents and related products, which are valued for their quality and accuracy. These include:

In vitro Diagnostic Reagents & Assays

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Real time PCR kits

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Analysers and instruments

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Contract Manufacturing of IVD Reagents

We also distribute IVD products from the UK to EU countries for manufacturers based outside the EU. We also offer a bespoke contract manufacturing service. When it comes to both distribution and contract manufacturing, our customers benefit not only from our experience and expertise as an IVD manufacturer but also from our ease of access to the European Single & UK markets.
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Diabetes & HbA1c Testing

Diabetes is a serious issue all over the world. It has reached epidemic levels in most countries, and the number of people affected by the disease is increasing.

Prestige Diagnostics are at the forefront of diabetes monitoring, and specialise in haemoglobin A1c (HbA1c) testing.

HbA1c testing involves measuring the amount of glucose attached to a patient’s haemoglobin, which has significant advantages over conventional blood glucose testing. Haemoglobin, which is a protein found in the red blood cells, binds with glucose in the bloodstream in a process called glycation. This glycated haemoglobin (HbA1c) remains in the red blood cells for their lifespan of 8 to 12 weeks.

By measuring how much HbA1c is in the blood, you can check a patient’s blood sugar levels over the previous two or three months – not just at a given point in time. It also has the added advantage that the patient doesn’t have to fast beforehand. For these reasons, HbA1c testing is being used increasingly, except for patients with type 1 diabetes and certain other.
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Point Of Care Diagnostics

Point-of-care testing (POCT) is a huge trend in healthcare. It takes testing and analysis out of the hands of central laboratories and gives the responsibility to healthcare professionals at the point of care: the people who are dealing with patients with diabetes, cancer, kidney disease or whatever they may or may not be suffering from.

Test results can now be analysed at the point of care using small portable analysers. This saves time and money and offers clear benefits to both healthcare providers and patients. As an IVD manufacturer that follows market trends closely, we will continue to maintain a strong focus on this growing market. While 90% of what we currently supply is for central laboratory testing, we expect this percentage to fall to 60% in the foreseeable future as the point-of-care market grows in importance.
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Diagnostic Solutions

High-quality clinical diagnostic and point-of-care products

Why Work with Prestige Diagnostics?

Agile, Adaptable and Focused on Quality and Reliability In Vitro Diagnostic Medical Devices Manufacturer

As an innovative IDV Manufacturer, we are highly experienced, agile and able to respond quickly to clinical & biological requirements. Whilst also maintaining a razor-sharp focus on quality and reliability.

State-of-the-Art In Vitro Diagnostic Manufacturing

We have finely tuned procurement, production, warehousing and distribution processes and operate a state-of-the-art in vitro diagnostic manufacturing facility.

ISO-Certified Quality Management System

Quality and reliability are of the utmost importance to us. Our quality management system is certified to ISO 13485:2016.

Full Regulatory Compliance

We are registered with the MHRA (Medicines and Healthcare products Regulatory Agency), which is an executive agency of the UK government. That enables us to apply for the certificate of free sale that most of our distributors worldwide require.

In Vitro Diagnostic Medical Devices Manufacturer Located in Northern Ireland, Part of the UK and the European Single Market

Unlike the rest of the UK, Northern Ireland has remained in the European single market, as set out in the Northern Ireland Protocol. Consequently, we benefit from frictionless trade with both the UK and EU countries.

Ethical Business Practices

We are a values-led business, and as such, all our relationships are characterised by honesty, integrity and trust. Prestige Diagnostics is, above all, an experienced, reliable business partner – one that offers significant IVD expertise and keeps a keen eye on developments in the constantly evolving IVD marketplace. We believe in dealing fairly with all our customers and distributors in a spirit of partnership.

If you have a question or would like to discuss how we might be able to help, please contact us here to speak to one of our specialists. We are always happy to help.

Explore our other services

We manufacture a range of well over 100 

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Contract Manufacturing

Bespoke manufacturing services

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Become a Distributor

If you are interested in distributing our range of products, please
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Distribution

Bespoke distribution services
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Ease of Access

The Northern Ireland Protocol ensures that Northern Ireland, which is part of the UK, also remains part of the EU single market despite Brexit
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