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U.S. Department of Health and Human Services

Product Classification

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Device cancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma
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.
Physical State Assay kit including capturing and detecting antibody, buffers, controls and calibrators.
Technical Method Enzyme-linked Immunosorbent Assay (ELISA)
Target Area In vitro diagnostic test usinh human serum.
Review Panel Immunology
Product CodeOAW
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE - Humanitarian Device Exemption
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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