OAW

Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma

Product code: OAW
Device name: Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma
Device class: Class F
Medical specialty: Unknown
Marketing pathway: HDE - Humanitarian Device Exemption

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OAW

Classification and pathway per current FDA publications. Data from openFDA (CC0).