Device Dossier

Clinical chemistry autoimmune IVDs

Device Dossier for Clinical chemistry autoimmune IVDs (CT869 - Clinical chemistry autoimmune IVDs, Class 2, sponsor Integrated Sciences). ARTG record,…

Intended purpose

IVDs that are intended to be used for the qualitative and or quantitative determination of autoimmune markers in a clinical specimen. Each IVD is intended to be used by a medical laboratory scientist. Techniques used include: ELISA, Indirect Immunofluorescence and Quickcard.

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