PMA
BP170154: ID CORE XT
FDA PMA · Molecular erythrocyte typing test · Progenika Biopharma, S.A.
Key facts
| PMA number | BP170154 |
|---|---|
| Trade name | ID CORE XT |
| Generic name | Molecular erythrocyte typing test |
| Applicant | Progenika Biopharma, S.A. |
| Owner/operator | Progenika Biopharma S.A. |
| Product code | PEP |
| Approval date | Oct 11, 2018 |
| Establishment registration | 3006413195 |
| FEI number | 3006413195 |
At a glance
- 1–9 Supplements
- Apr 12, 2022 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- No Withdrawn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: