PMA
P210022: Alinity m CMV
FDA PMA · Cytomegalovirus (cmv) dna quantitative assay · Abbott Molecular, Inc.
Key facts
| PMA number | P210022 |
|---|---|
| Trade name | Alinity m CMV |
| Generic name | Cytomegalovirus (cmv) dna quantitative assay |
| Applicant | Abbott Molecular, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | PAB |
| Approval date | May 5, 2022 |
| Docket number | 22M-0773 |
| Notice date | May 10, 2022 |
| Establishment registration | 3005248192 |
| FEI number | 3005248192 |
At a glance
- 10–99 Supplements
- Sep 13, 2024 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: