OYB · Kit, Rna Detection, Human Papillomavirus
· Class 3
Overview
| Product Code | OYB |
|---|---|
| Device Name | Kit, Rna Detection, Human Papillomavirus |
| Device Class | Class 3 |
| Review Panel |
Identification
For the detection of human papillomavirus RNA to aid in assessing risk of cancer.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P120007 | APTIMA HPV 16 18/45 GENOTYPE ASSAY | Gen-Probe Incorporated | Oct 12, 2012 | APPR |
| P100042 | APTIMA HPV ASSAY | Gen-Probe Incorporated | Oct 28, 2011 | APPR |
Top Applicants
- Gen-Probe Incorporated — 2 clearances
