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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device qualitative cytomegalovirus nucleic acid-based detection device for congenital cytomegalovirus infection
Definition The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies.
Product CodeQDZ
Regulation Number 866.3181
Device Class 2


Premarket Reviews
ManufacturerDecision
DIASORIN MOLECULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1

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