PMA
P150042: ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM
FDA PMA · ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM · Zeus Scientific, Inc.
Key facts
| PMA number | P150042 |
|---|---|
| Trade name | ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM |
| Generic name | ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM |
| Applicant | Zeus Scientific, Inc. |
| Owner/operator | ZEUS SCIENTIFIC LLC |
| Product code | MYM |
| Approval date | Sep 19, 2017 |
| Docket number | 17M-5863 |
| Notice date | Sep 22, 2017 |
| Establishment registration | 2242436 |
| FEI number | 2242436 |
At a glance
- None Supplements
- Sep 19, 2017 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- No Withdrawn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: