Device Dossier

Multiple clinical chemistry constituent IVDs

Device Dossier for Multiple clinical chemistry constituent IVDs (CT889 - Multiple clinical chemistry constituent IVDs, Class 2, sponsor Ortho-Clinical…

Intended purpose

IVDs intended to be used for the qualitative and/or quantitative determination of multiple analytes (chemical, biological, and/or immunological) from more than one clinical chemistry specialty, in a clinical specimen

TGA Public Summary