Cervical Intraepithelial Neoplasia (cin) Test System
Pathology · 21 CFR 864.1865
The p16 CIN test system is a qualitative immunohistochemistry (IHC) test to assess the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues. It is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of CIN. Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information.
Recent MDR events
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Event type breakdown
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Recalls
3 recall events for this product code
- Ventana Medical Systems IncTerminatedSep 14, 2018
CINtec Histology (250), Catalog Number 06680011001, model 725-4793
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Z-3011-2018 · View FDA record ↗ - Ventana Medical Systems IncTerminatedSep 14, 2018
CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Z-3012-2018 · View FDA record ↗ - Ventana Medical Systems IncTerminatedSep 14, 2018
CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Z-3013-2018 · View FDA record ↗
Registered firms
2 firms currently registered for this product code
510(k) clearances
2 clearances for this product code