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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
Regulation Description Respiratory viral panel multiplex nucleic acid assay.
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
ROCHE MOLECULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics, Inc. II Jun-11-2025
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