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U.S. Department of Health and Human Services

Product Classification

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Device droplet digital pcr system
Definition A digital polymerase chain reaction system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample.This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis.
Physical State n/a
Technical Method n/a
Target Area IVD
Review Panel Clinical Chemistry
Product CodePHG
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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
Third Party Review Not Third Party Eligible
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