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U.S. Department of Health and Human Services

Product Classification

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Device cytokeratin fragments 21-1 eia kit
Regulation Description Tumor-associated antigen immunological test system.
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.
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 Medical Specialty Immunology
Review Panel Immunology
Product CodeOVK
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.6010
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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