PMA
BP130026: Immucor PreciseType™ Human Erythrocyte Antigen Molecular BeadChip Test
FDA PMA · Molecular erythrocyte typing test · BioArray Solutions, Ltd.
Key facts
| PMA number | BP130026 |
|---|---|
| Trade name | Immucor PreciseType™ Human Erythrocyte Antigen Molecular BeadChip Test |
| Generic name | Molecular erythrocyte typing test |
| Applicant | BioArray Solutions, Ltd. |
| Owner/operator | BioArray Solutions Limited |
| Product code | PEP |
| Approval date | May 21, 2014 |
| Establishment registration | 3005967741 |
| FEI number | 3005967741 |
At a glance
- 1–9 Supplements
- Apr 14, 2017 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- No Withdrawn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: