Product code
OAW: Cancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma
FDA product code · HDE · Immunology
Key facts
| Product code | OAW |
|---|---|
| Device | Cancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma |
| Device class | HDE |
| Review panel | Immunology |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A quantitative measurement of soluble mesothelin related peptides (smrp) in human serum. Measurement of smrp may aid in the monitoring of mesothelioma patients diagnosed with epithelioid or biphasic mesothelioma. Values must be interpreted in conjunction with all other available clinical laboratory data. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- 1–9 HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database