Device Dossier
Rapid Diagnostics DivisionT/A Alere - Clinical chemistry hormone IVDs
Device Dossier for Rapid Diagnostics DivisionT/A Alere - Clinical chemistry hormone IVDs (CT850 - Clinical chemistry hormone IVDs, Class 2, sponsor…
- GMDN category: CT850 - Clinical chemistry hormone IVDs
Intended purpose
Intended to be used for the detection of clinical hormones such as IGFBP-1 (insulin-like growth factor binding protein-1) in vaginal or cervical samples to aid in the diagnosis of pregnancy complications.