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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State In vitro diagnostic device
Technical Method In vitro diagnostic device
Target Area In vitro diagnostic device
Review Panel Pathology
Product CodeOQS
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Molecular Genetics and Pathology (DMGP)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible