Pure Global AI
FDA product code OAW

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

UnknownClass f21 CFR
Verified
US regulatory classifications
US Product Code (FDA)
OAW
View Product Code Classification
US Risk Class (FDA)
Class f
US Regulation (CFR)
21 CFR
View CFR Regulation
Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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01Cancer Monitoring02Mesothelioma Test03Peptide Biomarker04Tumor Marker05Diagnostic Test06Oncology Test07Cancer Screening08Biomarker Detection09IVD Test10Mesothelin
About this record

Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.