Randox Laboratories
Privately held British manufacturer of clinical diagnostic reagents and biochip array systems.
Updated Jul 1, 2026
Headquartered in United Kingdom
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Overview
About Randox Laboratories
Randox Laboratories manufactures clinical diagnostic reagents and biochip array testing systems used by laboratories worldwide, and is a privately held manufacturer headquartered in County Antrim, United Kingdom.
Products
- Clinical diagnostic reagents
- Biochip array diagnostic systems
Markets Served
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Related
Certifications
ISO 13485
The international quality management system standard specific to medical device manufacturers, referenced by most major regulators.
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CE Mark
The conformity mark required to sell medical devices in the EU/EEA, issued once a device meets EU MDR or IVDR requirements.
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FDA 510(k) / PMA
US market authorization for medical devices via the FDA's 510(k), De Novo, or PMA pathways.
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UKCA
The UK's post-Brexit conformity mark for the Great Britain market, overseen by the MHRA.
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Related
Regulatory Pathways
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