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U.S. Department of Health and Human Services

Product Classification

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Device test, epithelial ovarian tumor-associated antigen (ca125)
Regulation Description Tumor-associated antigen immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeLTK
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.6010
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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