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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device variola virus nucleic acid-based detection assay
Definition The Variola virus nucleic acid-based detection assay is intended for individuals presenting with pustular or vesicular rash illness or other signs and symptoms of Variola virus infection. The test results must be used in conjunction with other diagnostic assays and clinical observations, as an aid to the diagnosis of infection, in accordance with the criteria defined by the appropriate public health authorities with the Federal government.
Product CodePRA
Regulation Number 866.3316
Device Class 2

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