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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device non-variola orthopoxvirus real-time pcr primer and probe set
Definition In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.
Product CodePBK
Regulation Number 866.3315
Device Class 2


Premarket Reviews
ManufacturerDecision
CENTERS FOR DISEASE CONTROL AND PREVENTION
  SUBSTANTIALLY EQUIVALENT 3

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