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…
- GMDN category: CT869 - Clinical chemistry autoimmune IVDs
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.