Product code MAQ
- Device name
- Kit, Dna Detection, Human Papillomavirus
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P160037S027 | BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR™ HPV Extraction Trough (SKU 444074) | Becton, Dickinson and Company | 2026-08-19 |
| P160037S028 | BD Onclarity™ HPV Assay | Becton, Dickinson and Company | 2026-08-14 |
| P230003S015 | Alinity m HR HPV | Abbott Molecular, Inc. | 2026-07-23 |
| P230003S018 | Alinity m HR HPV | Abbott Molecular, Inc. | 2026-06-22 |
| P190028S023 | cobas HPV | Roche Molecular Systems, Inc. | 2026-06-16 |
| P230003S014 | Alinity m HR HPV Assay | Abbott Molecular, Inc. | 2026-06-08 |
| P230003S017 | Alinity m HR HPV | Abbott Molecular, Inc. | 2026-05-28 |
| P230003S016 | Alinity m HR HPV | Abbott Molecular, Inc. | 2026-05-19 |
| P230003S013 | Alinity m HR HPV | Abbott Molecular, Inc. | 2026-05-15 |
| P190028S024 | cobas® HPV | Roche Molecular Systems, Inc. | 2026-04-23 |
| P160037S025 | BD Onclarity HPV Assay | Becton, Dickinson and Company | 2026-04-02 |
| P160037S024 | BD Onclarity HPV Assay | Becton, Dickinson and Company | 2026-04-02 |
| P190028S025 | cobas® HPV | Roche Molecular Systems, Inc. | 2026-03-17 |
| P100020S065 | cobas® HPV | Roche Molecular Systems, Inc. | 2026-03-17 |
| P230003S011 | Alinity m HR HPV | Abbott Molecular, Inc. | 2026-03-12 |
| P230003S012 | Alinity m HR HPV | Abbott Molecular, Inc. | 2026-02-24 |
| P160037S026 | BD FOX™ PCR Extraction Tubes; BD Onclarity™ HPV Assay | Becton, Dickinson and Company | 2026-02-12 |
| P230003S010 | Alinity m HR HPV | Abbott Molecular, Inc. | 2026-01-06 |
| P190028S022 | cobas® HPV | Roche Molecular Systems, Inc. | 2025-12-31 |
| P100020S064 | cobas® HPV | Roche Molecular Systems, Inc. | 2025-12-31 |
| P100020S063 | COBAS HPV TEST | Roche Molecular Systems, Inc. | 2025-12-15 |
| P230003S009 | Alinity m HR HPV | Abbott Molecular, Inc. | 2025-10-17 |
| P230003S008 | Alinity m HR HPV | Abbott Molecular, Inc. | 2025-09-24 |
| P190028S021 | cobas HPV | Roche Molecular Systems, Inc. | 2025-09-19 |
| P230003S006 | Alinity m HR HPV | Abbott Molecular, Inc. | 2025-09-10 |
| P160037S022 | BD ONCLARITY HPV ASSAY | Becton, Dickinson and Company | 2025-08-25 |
| P190028S020 | cobas® HPV | Roche Molecular Systems, Inc. | 2025-08-07 |
| P160037S023 | BD Onclarity HPV Assay | Becton, Dickinson and Company | 2025-07-02 |
| P230003S007 | Alinity m HR HPV | Abbott Molecular, Inc. | 2025-04-18 |
| P190028S019 | cobas HPV for use on the cobas 6800/8800 Systems | Roche Molecular Systems, Inc. | 2025-03-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884999051928 | Alinity m | ABBOTT MOLECULAR INC. | 2026-07-27 |
| 00884999051287 | Alinity m | ABBOTT MOLECULAR INC. | 2026-04-13 |
| 00382904454166 | BD Onclarity HPV Self Collection Diluent Tube | BECTON, DICKINSON AND COMPANY | 2024-11-01 |
| 30382904454167 | BD Onclarity HPV Self Collection Diluent Tube | BECTON, DICKINSON AND COMPANY | 2024-11-01 |
| 30382904454365 | BD Copan FLOQSwabs for HPV Self Collection | BECTON, DICKINSON AND COMPANY | 2024-10-09 |
| 00382904454364 | FLOQSwabs for HPV Self Collection | BECTON, DICKINSON AND COMPANY | 2024-10-09 |
| 30382904440726 | BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes | BECTON, DICKINSON AND COMPANY | 2024-09-13 |
| 00382904440725 | BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes | BECTON, DICKINSON AND COMPANY | 2024-09-13 |
| 30382904440740 | BD Onclarity™ HPV Extraction Reagent Trough for BD COR™ | BECTON, DICKINSON AND COMPANY | 2024-07-26 |
| 00382904440749 | BD Onclarity™ HPV Extraction Reagent Trough for BD COR™ | BECTON, DICKINSON AND COMPANY | 2024-07-26 |
| 00875197006896 | cobas HPV Positive Control Kit | Roche Molecular Systems, Inc. | 2024-06-06 |
| 00875197006889 | cobas HPV | Roche Molecular Systems, Inc. | 2024-06-05 |
| 00382904440756 | BD Onclarity™ HPV Assay Reagent Pack | BECTON, DICKINSON AND COMPANY | 2024-04-29 |
| 30382904440832 | BD Onclarity™ HPV Assay Diluent for BD COR™ | BECTON, DICKINSON AND COMPANY | 2024-02-28 |
| 00382904440831 | BD Onclarity™ HPV Assay Diluent for BD COR™ | BECTON, DICKINSON AND COMPANY | 2024-02-28 |
| 00382904439903 | BD COR™ GX INSTRUMENT | BECTON, DICKINSON AND COMPANY | 2024-02-16 |
| 00382904439880 | BD COR™ PX INSTRUMENT | BECTON, DICKINSON AND COMPANY | 2024-02-16 |
| 00884999048676 | Alinity m | ABBOTT MOLECULAR INC. | 2024-01-02 |
| 00884999048621 | Alinity m | ABBOTT MOLECULAR INC. | 2024-01-02 |
| 00884999048614 | Alinity m | ABBOTT MOLECULAR INC. | 2024-01-02 |
| 00382904453282 | BD Onclarity™ HPV LBC Diluent Tubes | BECTON, DICKINSON AND COMPANY | 2023-10-26 |
| 30382904453283 | BD Onclarity™ HPV LBC Diluent Tubes | BECTON, DICKINSON AND COMPANY | 2023-10-26 |
| 30382904453290 | BD Onclarity™ HPV SurePath™ Diluent Tubes | BECTON, DICKINSON AND COMPANY | 2023-10-25 |
| 00382904453299 | BD Onclarity™ HPV SurePath™ Diluent Tubes | BECTON, DICKINSON AND COMPANY | 2023-10-25 |
| 00875197005769 | cobas HPV Positive Control | Roche Molecular Systems, Inc. | 2021-06-04 |
| 00875197005752 | cobas HPV for use on the cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2021-06-04 |
| 30382904440894 | BD FOX™ PCR Extraction Tubes | BECTON, DICKINSON AND COMPANY | 2020-02-19 |
| 30382904440870 | BD Viper™ PCR Extraction Reagent Trough with Piecring Tool | BECTON, DICKINSON AND COMPANY | 2020-02-19 |
| 30382904438372 | BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes | BECTON, DICKINSON AND COMPANY | 2020-02-19 |
| 04015630929016 | cobas z 480 | Roche Molecular Systems, Inc. | 2014-09-15 |