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U.S. Department of Health and Human Services

Product Classification
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Device placental growth factor test
Definition For quantitative determination of Placental Growth Factor (PlGF).
Physical State In Vitro Diagnostic (IVD)
Technical Method Immunoassay
Target Area In Vitro Diagnostic (IVD)
Review Panel Toxicology
Product CodePZN
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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