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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assayed external control material for microbiology nucleic acid amplification (nat) assays
Regulation Description Assayed quality control material for clinical microbiology assays.
Definition Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
Product CodePMN
Regulation Number 866.3920
Device Class 2


Premarket Reviews
ManufacturerDecision
MAINE MOLECULAR QUALITY CONTROLS, INC.
  SUBSTANTIALLY EQUIVALENT 7
STRECK
  SUBSTANTIALLY EQUIVALENT 3
STRECK, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRECK, LLC
  SUBSTANTIALLY EQUIVALENT 2
ZEPTOMETRIX
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fail-Safe Did Not Operate 1 1
Human-Device Interface Problem 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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