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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device respiratory specimen nucleic acid sars-cov-2 test
Definition A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The device is intended to aid in the diagnosis of COVID-19 in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.
Product CodeQQX
Regulation Number 866.3981
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOFIRE DEFENSE, LLC
  SUBSTANTIALLY EQUIVALENT 2
CEPHEID®
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN MOLECULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
ROCHE MOLECULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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