HDE
H130004: PLEXIMMUNE ASSAY
FDA Humanitarian Device Exemption · PLEXISION INC.
Key facts
| HDE number | H130004 |
|---|---|
| Trade name | PLEXIMMUNE ASSAY |
| Generic name | Test, cell mediated immune response, liver and small bowel transplant/transplantation |
| Applicant | PLEXISION INC. |
| Owner/operator | PLEXISION, INC |
| Product code | PHK |
| Approval date | Aug 26, 2014 |
| Docket number | 14M-1280 |
| Notice date | Sep 10, 2014 |
| Establishment registration | 3009099956 |
| FEI number | 3009099956 |
At a glance
- None Supplements
- Aug 26, 2014 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None 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 HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: