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U.S. Department of Health and Human Services

Product Classification

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Device test, qualitative and quantitative factor deficiency
Regulation Description Factor deficiency test.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGGP
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.7290
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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