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U.S. Department of Health and Human Services

Product Classification
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Device laboratory developed test
Definition Laboratory Developed Test
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 Division of Molecular Genetics and Pathology (DMGP)
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
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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