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Check company, site and product certificates - Validation and Verification, UK and global companies

Randox Laboratories Limited
55 Diamond Road
Crumlin
BT29 4QY
United Kingdom

Certificate number: MD 686778
Scope: The manufacture, of in-vitro diagnostic medical devices, in-vitro diagnostic test kits, in-vitro diagnostic reagents, calibrators and controls used in diagnosis and management of cancer, diagnosis of immune status, disease status and autoimmune status, and the identification of drugs of abuse, cardiac markers, protein metabolism, endocrine disorders, blood analytes, blood components, blood gases, coagulation, transmissible agents, sexually transmissible agents, fertility and for immunological typing and therapeutic drug monitoring. The manufacture of companion diagnostics.

Standard/Scheme number or name	Start Date	Expiry Date
ISO 13485: 2016	2018-03-19	2028-11-05

Certificate number: MDSAP 699499
Scope: The manufacture of in-vitro diagnostic medical devices, invitro diagnostic test kits, in-vitro diagnostic reagents, calibrators and controls used in diagnosis and management of cancer, diagnosis of immune status, disease status and autoimmune status, and the identification of drugs of abuse, cardiac markers, protein metabolism, endocrine disorders, blood analytes, blood components, blood gases, coagulation, transmissible agents, sexually transmissible agents, fertility and for immunological typing and therapeutic drug monitoring. The manufacture of companion diagnostics.

Standard/Scheme number or name	Start Date	Expiry Date
MDSAP	2019-11-06	2028-11-05

Certificate number: GB1246W
Scope:

Standard/Scheme number or name	Start Date	Expiry Date
	2022-04-25

Certificate number: IS 769911
Scope: The support of the technology services, operations, development activities, and supporting functions, to the Randox Group worldwide. This is in accordance with the Statement of Applicability, Version B, dated 26/09/25.

Standard/Scheme number or name	Start Date	Expiry Date
ISO/IEC 27001:2022	2023-01-25	2029-01-24