Cervical Intraepithelial Neoplasia (Cin) Test System
PRB is the FDA product code for Cervical Intraepithelial Neoplasia (Cin) Test System, a class II device type, regulated under 21 CFR 864.1865. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 3 recalls.
Classification record
- Product code
- PRB
- Device name
- Cervical Intraepithelial Neoplasia (Cin) Test System
- 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.
- Regulation
- 21 CFR 864.1865
- Device class
- Class II
- Review panel
- Pathology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 3
Clearances, product code PRB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2021 | 1 |
Applicants with the most clearances
Product code PRB| Applicant | Clearances |
|---|---|
| Ventana Medical Systems Inc | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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