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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laboratory developed test
Definition A clinical diagnostic test for use in the diagnosis of disease or other conditions that was developed by CLIA certified clinical laboratory for use in that laboratory. This product is neither an Analyte Specific Reagent nor are the components for Research Use Only. The reporting of adverse events is voluntary and registering and listing is not required.
Product CodeOQS
Device Class Not Classified

Device Problems
Inappropriate shock 1
Total Device Problems 1