Device Dossier
Acquired genetic alteration IVDs
Device Dossier for Acquired genetic alteration IVDs (CT929 - Acquired genetic alteration IVDs, Class 3, sponsor Carl Zeiss). ARTG record, intended…
- GMDN category: CT929 - Acquired genetic alteration IVDs
Intended purpose
IVDs that are intended to be used for fluorescent insitu hybridization (FISH) to provide information about acquired genetic alterations, which may include chromosomal alterations, and which may be used to characterize hematological or solid tumor malignancies and/or provide prognostic information (CT929 Acquired genetic alteration IVDs). These products are intended for use as an adjunct to clinical and pathological information and not as independent tests or assays.