PRB
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cervical Intraepithelial Neoplasia (Cin) Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1865
- Medical specialty
- Pathology
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| CINtec Histology (K212176) | Ventana Medical Systems, Inc. | 2021-12-10 |
| CINtec Histology (50 tests), CINtec Histology (250 tests) (DEN160019) | Ventana Medical Systems, Inc. | 2017-03-04 |
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