All products are certified for diagnostic use under IVDR, and within the UK are IVDD registered.
They retain their CE mark outside of UK under IVDR and hold the UKCA mark within the UK.
These exacting quality standards to which Atom are one of the few UK manufacturers in full compliance means we can play a part in our laboratory customers’ own compliance with quality management systems, such as ISO15189 for quality and competence in medical laboratories.
Since 2018, Atom have participated in the UK NEQAS CPT (Cellular Pathology Technique) scheme as an independent validation of our in-house lab testing results.
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Sudan Black B Stain Kit (Haematology Version) |