HDE supplement
H060004 S008: MESOMARK
FDA HDE supplement · 30-day notice · Fujirebio Diagnostics, Inc.
Key facts
| Original HDE | H060004 |
|---|---|
| Supplement number | S008 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | MESOMARK |
| Generic name | Cancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma |
| Applicant | Fujirebio Diagnostics, Inc. |
| Product code | OAW |
| Received date | Dec 9, 2020 |
| Decision date | Jan 5, 2021 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: