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U.S. Department of Health and Human Services

Product Classification

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Device salivary estriol test
Definition To detect and measure salivary estriol in pregnant women.
Physical State Pregnancy
Technical Method Enzyme linked immunoabsorbent assay
Target Area saliva sample
Review Panel Clinical Chemistry
Product CodePEJ
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
Third Party Review Not Third Party Eligible
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