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Cytokeratin Fragments 21-1 Eia Kit

FDA product code OVK · 3 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.6010
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2011-05-26 – 2025-12-16

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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