# OYB · Kit, Rna Detection, Human Papillomavirus

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/MI-misc/OYB

## Overview

- **Product Code:** OYB
- **Device Name:** Kit, Rna Detection, Human Papillomavirus
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## 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](https://fda.innolitics.com/submissions/MI/MI-misc/OYB/P120007.md) | APTIMA HPV 16 18/45 GENOTYPE ASSAY | Gen-Probe Incorporated | Oct 12, 2012 | APPR |
| [P100042](https://fda.innolitics.com/submissions/MI/MI-misc/OYB/P100042.md) | APTIMA HPV ASSAY | Gen-Probe Incorporated | Oct 28, 2011 | APPR |

## Top Applicants

- Gen-Probe Incorporated — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/MI/MI-misc/OYB](https://fda.innolitics.com/submissions/MI/MI-misc/OYB)

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