OVKClass II
Cytokeratin Fragments 21-1 Eia Kit
Immunology · 21 CFR 866.6010
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.
MDR events8All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances3All time
Recent MDR events
8 adverse event reports on file
- ELECSYS CYFRA 21-1Apr 14, 2025MalfunctionRoche Diagnostics1823260-2025-01123
- ELECSYS CYFRA 21-1Jul 12, 2024MalfunctionRoche Diagnostics1823260-2024-02004
- ELECSYS CYFRA 21-1Apr 5, 2024MalfunctionRoche Diagnostics1823260-2024-01054
- ELECSYS CYFRA 21-1Nov 16, 2023MalfunctionRoche Diagnostics1823260-2023-03631
- ELECSYS CYFRA 21-1Mar 17, 2023MalfunctionRoche Diagnostics1823260-2023-00863
- ELECSYS CYFRA 21-1Aug 5, 2022MalfunctionRoche Diagnostics1823260-2022-02312
- ELECSYS CYFRA 21-1Oct 23, 2020MalfunctionRoche Diagnostics1823260-2020-02631
- CYTOKERATIN FRAGMENTS 21-1 EIA KITMar 25, 2020MalfunctionRoche Diagnostics1823260-2020-00838
Event type breakdown
Malfunction8
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
3 clearances for this product code