PMA
P190028: cobas HPV for use on the cobas 6800/8800 Systems
FDA PMA · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS · Roche Molecular Systems, Inc.
Key facts
| PMA number | P190028 |
|---|---|
| Trade name | cobas HPV for use on the cobas 6800/8800 Systems |
| Generic name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Applicant | Roche Molecular Systems, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | MAQ |
| Approval date | Apr 3, 2020 |
| Docket number | 20M-1213 |
| Notice date | Apr 7, 2020 |
| Establishment registration | 2243471 |
| FEI number | 2243471 |
At a glance
- 10–99 Supplements
- Jun 16, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: