HDE
H140006: KIT D816V ASSAY
FDA Humanitarian Device Exemption · ARUP LABARATORIES
Key facts
| HDE number | H140006 |
|---|---|
| Trade name | KIT D816V ASSAY |
| Generic name | Somatic gene mutation detection system |
| Applicant | ARUP LABARATORIES |
| Product code | OWD |
| Approval date | Dec 18, 2015 |
| Docket number | 15M-4949 |
| Notice date | Jan 14, 2016 |
At a glance
- None Supplements
- Dec 18, 2015 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: