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U.S. Department of Health and Human Services

Product Classification

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Device assay,enzyme linked immunosorbent,parvovirus b19 igm
Review Panel Microbiology
Product CodeMYM
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19 [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM094262.pdf] 
Third Party Review Not Third Party Eligible
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