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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 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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