# MAQ · Kit, Dna Detection, Human Papillomavirus

_ ·  · Class 3_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/MAQ

## Overview

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

## Recent Cleared Devices (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P230003S006](/device/P230003S006.md) | Alinity m HR HPV | Abbott Molecular, Inc. | Sep 10, 2025 | APPR |
| [P190028S009](/device/P190028S009.md) | cobas HPV | Roche Molecular Systems, Inc. | May 14, 2024 | APPR |
| [P160037S017](/device/P160037S017.md) | BD Onclarity HPV Assay | Becton, Dickinson and Company | May 14, 2024 | APPR |
| [P100020S055](/device/P100020S055.md) | cobas HPV Test | Roche Molecular Systems, Inc. | May 14, 2024 | APPR |
| [P230003](/device/P230003.md) | Alinity m HR HPV | Abbott Molecular, Inc. | Nov 1, 2023 | APPR |
| [P190028](/device/P190028.md) | cobas HPV for use on the cobas 6800/8800 Systems | Roche Molecular Systems, Inc. | Apr 3, 2020 | APPR |
| [P160037](/device/P160037.md) | BD ONCLARITY HPV ASSAY | Becton, Dickinson and Company | Feb 12, 2018 | APPR |
| [P100020S017](/device/P100020S017.md) | COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS | Roche Molecular Systems, Inc. | Jul 7, 2016 | APPR |
| [P100020S008](/device/P100020S008.md) | COBAS HPV TEST | Roche Molecular Systems, Inc. | Apr 24, 2014 | APPR |
| [P100020](/device/P100020.md) | COBAS HPV TEST | Roche Molecular Systems, Inc. | Apr 19, 2011 | APPR |
| [P080015](/device/P080015.md) | CERVISTA HPV 16/18 | Hologic, Inc. | Mar 12, 2009 | APWD |
| [P080014](/device/P080014.md) | CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT | Hologic, Inc. | Mar 12, 2009 | APWD |
| [P890064S009](/device/P890064S009.md) | DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST | Qiagen Gaithersburg, Inc. | Mar 31, 2003 | APPR |
| [P890064](/device/P890064.md) | VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT | Qiagen Gaithersburg, Inc. | Mar 11, 1991 | APPR |
| [P880009](/device/P880009.md) | VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT | Qiagen, Inc. | Dec 23, 1988 | APWD |

## Top Applicants

- Roche Molecular Systems, Inc. — 6 clearances
- Abbott Molecular, Inc. — 2 clearances
- Becton, Dickinson and Company — 2 clearances
- Hologic, Inc. — 2 clearances
- Qiagen Gaithersburg, Inc. — 2 clearances

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**Source:** [https://fda-staging.innolitics.com/productcode/MAQ](https://fda-staging.innolitics.com/productcode/MAQ)

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