HDE
H230005: nAbCyte Anti-AAVRh74var HB-FE Assay
FDA Humanitarian Device Exemption · LabCorp Drug Development
Key facts
| HDE number | H230005 |
|---|---|
| Trade name | nAbCyte Anti-AAVRh74var HB-FE Assay |
| Generic name | Assays to detect pre-existing antibodies to adeno-associated virus (aav) viral vectors |
| Applicant | LabCorp Drug Development |
| Product code | QWQ |
| Approval date | Apr 25, 2024 |
At a glance
- None Supplements
- Apr 25, 2024 Latest supplement decision
- Yes Summary of safety and probable benefit 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 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: