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 Conjunc
| Device Type ID | 3135 |
| Device Name | Cancer Monitoring Test System, Soluble Mesothelin-related Peptides, Epithelioid/biphasic Mesothelioma |
| 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 |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | OAW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |