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U.S. Department of Health and Human Services

Product Classification
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Device kit, test, alpha-fetoprotein for neural tube defects
Review Panel Immunology
Product CodeLOK
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Review Criteria for Assessment of Alpha-Fetoprotein (AFP) in vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM094248.pdf] 
Third Party Review Not Third Party Eligible
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