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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
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
BIO-RAD LABORATORIES
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1
BIOFIRE DEFENSE, LLC
  SUBSTANTIALLY EQUIVALENT 1
MAINE MOLECULAR QUALITY CONTROLS, INC.
  SUBSTANTIALLY EQUIVALENT 10
MICROBIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 8
STRECK
  SUBSTANTIALLY EQUIVALENT 2
STRECK, INC
  SUBSTANTIALLY EQUIVALENT 1
ZEPTOMETRIX
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Human-Device Interface Problem 1 1
Fail-Safe Did Not Operate 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 Microbiologics Inc III Jun-18-2019
2 Microbiologics Inc II Jun-04-2019
3 Microbiologics Inc II Mar-07-2019
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