About Lodestar DX

Lodestar DX is brought to the UK market through a partnership between two specialist organisations.

Manufacturer

Llusern Scientific

Llusern Scientific Ltd is a UK manufacturer of molecular diagnostic testing systems, based at Cardiff Edge Business Park in Cardiff. Its loop-mediated isothermal amplification (LAMP) work has been developed with the University of South Wales and Public Health Wales. Lodestar DX is Llusern's proprietary testing platform and is UKCA-marked, ISO 13485:2016 certified (BSI MD 812652), and registered with the MHRA (GMDN 64635). Lodestar is a registered trademark of Llusern Scientific Ltd.

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UK Distributor

Syner-Med

Syner-Med (Pharmaceutical Products) Ltd is a UK-based specialty pharmaceutical and medical device distributor with a focus on urology, women's health and bladder care. Syner-Med holds the UK distribution rights for Lodestar DX, with commercial responsibility for clinical evaluations, post-launch support, and adverse incident reporting in the UK market.

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Regulatory and quality

Registrations and certifications.

UKCA-marked

Lodestar DX is UKCA-marked for in vitro diagnostic use.

ISO 13485:2016

Llusern Scientific maintains ISO 13485:2016 certification for the design and manufacture of medical devices. BSI certificate MD 812652.

Registered with the MHRA

Llusern Scientific Ltd is registered with the UK Medicines and Healthcare products Regulatory Agency, manufacturer account 0000029762. Lodestar DX is registered under GMDN code 64635.

Published research

Peer-reviewed publications.

Evaluation of a rapid point-of-care molecular test for urinary tract infection in symptomatic adult women (Public Health Wales, Cardiff)
JAC-Antimicrobial Resistance (open access)
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Evaluation of the Lodestar DX: a comparison with traditional culture for the detection of bacteriuria (Norfolk and Norwich University Hospital)
JAC-Antimicrobial Resistance, 2025 (open access)
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Adverse incidents

How to report.

Adverse incidents relating to Lodestar DX should be reported to PV@syner-med.com and via the MHRA Yellow Card scheme. Refer to the Lodestar DX Instructions for Use for full safety and operational guidance.

MHRA Yellow Card scheme →

Change the way you manage UTIs.

For commercial, clinical and partnership enquiries, contact the Syner-Med team.

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