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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nucleic acid amplification test for the quantitation of epstein-barr virus (ebv) dna
Definition A quantitative viral nucleic acid test for transplant patient management is identified as a device intended for prescription use in the detection of viral pathogens by measurement of viral deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) using specified specimen processing, amplification, and detection instrumentation. The test is intended for use as an aid in the management of transplant patients with active viral infection or at risk for developing viral infections. The test results are intended to be interpreted by qualified healthcare professionals in conjunction with other relevant clinical and laboratory findings.
Product CodeQLX
Regulation Number 866.3183
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MOLECULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE MOLECULAR SYSTEMS, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1
  1.  K203220  cobas BKV

MDR Year MDR Reports MDR Events
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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