Definition: The CYFRA 21-1 EIA Kit Is Intended For The Quantitative Determination Of Soluble Cytokeratin 19 Fragments In Human Serum. The Assay Is To Be Used As An Aid In Monitoring Disease Progression During The Course Of Disease And Treatment In Lung Cancer Pa
| Device Type ID | 3091 |
| Device Name | Cytokeratin Fragments 21-1 Eia Kit |
| Physical State | Plastic Microtiter Plate, Plate Reader System |
| Technical Method | Enzyme Immunoassay To Quantify Soluble Cytokeratin 19 In Human Serum. |
| Target Area | Patient Serum |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6010 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OVK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3091 |
| Device | Cytokeratin Fragments 21-1 Eia Kit |
| Product Code | OVK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| CFR Regulation Number | 866.6010 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |