PMA
P130027: ARTUS CMV RGQ MDX KIT
FDA PMA · Cytomegalovirus (cmv) dna quantitative assay · Qiagen, Inc.
Key facts
| PMA number | P130027 |
|---|---|
| Trade name | ARTUS CMV RGQ MDX KIT |
| Generic name | Cytomegalovirus (cmv) dna quantitative assay |
| Applicant | Qiagen, Inc. |
| Owner/operator | QIAGEN, GmbH |
| Product code | PAB |
| Approval date | Jun 2, 2014 |
| Docket number | 14M-0866 |
| Notice date | Jun 30, 2014 |
| Establishment registration | 3004013603 |
| FEI number | 3004013603 |
At a glance
- 1–9 Supplements
- Sep 26, 2018 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- No Withdrawn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: