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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antisera, fluorescent, human metapneumovirus
Definition It is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimens or cell culture. The assay detects hMPV antigens by immunofluorescence using antibodies, from patients with signs and symptoms of acute respiratory infection. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV.
Product CodeOMG
Regulation Number 866.3980
Device Class 2


Premarket Reviews
ManufacturerDecision
DIAGNOSTIC HYBRIDS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MILLIPORE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

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