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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
Bio-Rad Laboratories
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1
BIO-RAD LABORATORIES, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1
MAINE MOLECULAR QUALITY CONTROLS, INC.
  SUBSTANTIALLY EQUIVALENT 5
MICROBIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 8

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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