PMA
P160052: PartoSure test
FDA PMA · Placental alpha microglobulin-1 immunoassay · Qiagen, Inc.
Key facts
| PMA number | P160052 |
|---|---|
| Trade name | PartoSure test |
| Generic name | Placental alpha microglobulin-1 immunoassay |
| Applicant | Qiagen, Inc. |
| Owner/operator | QIAGEN Sciences LLC |
| Product code | QBB |
| Approval date | Apr 11, 2018 |
| Docket number | 18M-1581 |
| Notice date | Apr 27, 2018 |
| Establishment registration | 1122376 |
| FEI number | 3003572099 |
At a glance
- 1–9 Supplements
- Oct 11, 2019 Latest supplement decision
- No Withdrawn
- Yes 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: