PMA
P890064: VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT
FDA PMA · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS · Qiagen Gaithersburg, Inc.
Key facts
| PMA number | P890064 |
|---|---|
| Trade name | VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT |
| Generic name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Applicant | Qiagen Gaithersburg, Inc. |
| Owner/operator | QIAGEN Sciences LLC |
| Product code | MAQ |
| Approval date | Mar 11, 1991 |
| Docket number | 91M-0108 |
| Notice date | Apr 10, 1991 |
| Establishment registration | 1122376 |
| FEI number | 3003572099 |
At a glance
- 10–99 Supplements
- Oct 19, 2023 Latest supplement decision
- No Withdrawn
- No 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: