Device Dossier

Clinical chemistry autoimmune IVDs

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

Intended purpose

The RF Latex Calibrator is a liquid human serum based matrix calibrator intended to be used with the RF Latex reagent OSR61105 for the quantitative determination of Rheumatoid Factor on Beckman Coulter analysers. Clinical chemistry autoimmune IVDs

TGA Public Summary