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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bordetella pertussis dna assay system
Definition A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.
Product CodeOZZ
Regulation Number 866.3980
Device Class 2


Premarket Reviews
ManufacturerDecision
DIASORIN MOLECULAR LLC
  SUBSTANTIALLY EQUIVALENT 2
GREAT BASIN SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUMINEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 2
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Recalls
Manufacturer Recall Class Date Posted
1 Luminex Corporation II Aug-15-2019
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