MAQ · Kit, Dna Detection, Human Papillomavirus
· Class 3
Overview
| Product Code | MAQ |
|---|---|
| Device Name | Kit, Dna Detection, Human Papillomavirus |
| Device Class | Class 3 |
| Review Panel |
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P230003S006 | Alinity m HR HPV | Abbott Molecular, Inc. | Sep 10, 2025 | APPR |
| P190028S009 | cobas HPV | Roche Molecular Systems, Inc. | May 14, 2024 | APPR |
| P160037S017 | BD Onclarity HPV Assay | Becton, Dickinson and Company | May 14, 2024 | APPR |
| P100020S055 | cobas HPV Test | Roche Molecular Systems, Inc. | May 14, 2024 | APPR |
| P230003 | Alinity m HR HPV | Abbott Molecular, Inc. | Nov 1, 2023 | APPR |
| P190028 | cobas HPV for use on the cobas 6800/8800 Systems | Roche Molecular Systems, Inc. | Apr 3, 2020 | APPR |
| P160037 | BD ONCLARITY HPV ASSAY | Becton, Dickinson and Company | Feb 12, 2018 | APPR |
| P100020S017 | COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS | Roche Molecular Systems, Inc. | Jul 7, 2016 | APPR |
| P100020S008 | COBAS HPV TEST | Roche Molecular Systems, Inc. | Apr 24, 2014 | APPR |
| P100020 | COBAS HPV TEST | Roche Molecular Systems, Inc. | Apr 19, 2011 | APPR |
| P080015 | CERVISTA HPV 16/18 | Hologic, Inc. | Mar 12, 2009 | APWD |
| P080014 | CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT | Hologic, Inc. | Mar 12, 2009 | APWD |
| P890064S009 | DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST | Qiagen Gaithersburg, Inc. | Mar 31, 2003 | APPR |
| P890064 | VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT | Qiagen Gaithersburg, Inc. | Mar 11, 1991 | APPR |
| P880009 | 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
