OVK
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cytokeratin Fragments 21-1 Eia Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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 patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer.
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| Record | Firm | Date |
|---|---|---|
| ADVIA Centaur Cytokeratin Fragment 21-1 (K250925) | Fujirebio Diagnostics,Inc. | 2025-12-16 |
| Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker (K160915) | Roche Diagnostics | 2016-12-14 |
| CYFRA 21-1 EIA MODEL 211-10 (K100831) | Fujirebio Diagnostics,Inc. | 2011-05-26 |
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