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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
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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