PMA
P880009: VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT
FDA PMA · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS · Qiagen, Inc.
Key facts
| PMA number | P880009 |
|---|---|
| Trade name | VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT |
| Generic name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Applicant | Qiagen, Inc. |
| Owner/operator | QIAGEN Sciences LLC |
| Product code | MAQ |
| Approval date | Dec 23, 1988 |
| Docket number | 88M-0446 |
| Notice date | Feb 28, 1989 |
| Establishment registration | 1122376 |
| FEI number | 3003572099 |
At a glance
- 1–9 Supplements
- May 17, 1993 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: