CE-IVD certified, ISO supported, traceable down to the lot.
Every assay we distribute carries a CE mark and full IFU documentation. Our service team is ISO-certified for installation, training and field maintenance.
Certifications
CE-IVD
All assays carry CE marks. EU IVDR-aligned documentation available on request.
ISO 9001 + 13485
Service team certified for medical device installation and maintenance.
Lot traceability
Every reagent lot tracked through delivery, storage and use at customer site.
Manufacturer pedigree
Snibe Diagnostic
Manufacturer of MAGLUMI X-series chemiluminescence analyzers. 25+ years in immunoassay. CE-IVD across the full catalogue, NMPA approved in China, expanding FDA submissions.
Sebia
Manufacturer of Alegria automated ELISA. Specialist in autoimmune and infectious disease serology. CE-IVD, ISO 13485, used in reference labs across Europe.
QC documentation policy
We supply Certificates of Analysis (CoA) for every reagent lot on delivery. Master calibrators and QC controls are traceable to international reference standards (WHO NIBSC, USP, ERM where applicable). Annual lot summary reports are available to QA managers on request.