HDE
H060004: MESOMARK
FDA Humanitarian Device Exemption · Fujirebio Diagnostics, Inc.
Key facts
| HDE number | H060004 |
|---|---|
| Trade name | MESOMARK |
| Generic name | Cancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma |
| Applicant | Fujirebio Diagnostics, Inc. |
| Owner/operator | Fujirebio Diagnostics, Inc. |
| Product code | OAW |
| Approval date | Jan 24, 2007 |
| Docket number | 07M0038 |
| Establishment registration | 2521625 |
| FEI number | 2521625 |
At a glance
- 1–9 Supplements
- Jan 5, 2021 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- 1–9 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: