QKFClass III
Immunocytochemistry Assay, P16/ki-67
Hematology · 21 CFR 864.1860
The p16 and Ki-67 antibody cocktail is a qualitative immunocytochemical assay intended for the simultaneous detection of the p16INK4a (E6H4) and Ki-67 (274-11AC3V1) proteins in cervical specimens collected by a clinician.
MDR events1All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances0All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Malfunction1
Most-reported manufacturers
Product problems
Reported product problem codes, most common first
False Positive Result1
Insufficient Device Problem Information1
Trend for “False Positive Result”
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
1 premarket approvals for this product code