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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assay, nucleic acid amplification, bacillus anthracis
Definition An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.
Product CodeNHT
Regulation Number 866.3045
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOFIRE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTERS FOR DISEASE CONTROL AND PREVENTION
  SUBSTANTIALLY EQUIVALENT 1
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 1 1
Naturally Worn 1 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Biofire Defense III Sep-15-2014
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