Device Dossier

Clinical chemistry autoimmune IVDs

Device Dossier for Clinical chemistry autoimmune IVDs (CT869 - Clinical chemistry autoimmune IVDs, Class 2, sponsor Bio-Strategy). ARTG record, intended…

Intended purpose

MosaiQ® AiPlex CTDplus is composed of single-use immunoassay microarrays to be used in conjunction with the automated MosaiQ 125 instrument and the associated MosaiQ reagents. It is intended for the in vitro quantitative measurement of IgG antibodies directed to dsDNA, semi-quantitative detection of IgG antibodies against various antigens including Extractable Nuclear Antigens (ENA): TRIM21 (SS-A52), SS-A 60, SSB, Sm, Sm/RNP, U1RNP, Scl- 70, Jo-1, Chromatin, CENP-B, Ribosomal P Protein, RNA Polymerase III, CCP2 and DFS70 in human serum.

TGA Public Summary