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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen
Definition A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.
Product CodeNQX
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
CEPHEID
  SUBSTANTIALLY EQUIVALENT 1
CEPHEID®
  SUBSTANTIALLY EQUIVALENT 1
LUMINEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 5 5
2023 12 12
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 23 23
False Positive Result 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
Drug Resistant Bacterial Infection 1 1
Cardiac Arrest 1 1
Septic Shock 1 1
Renal Impairment 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Aug-22-2019
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