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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gram-positive bacteria and their resistance markers
Regulation Description Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
Definition A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
Product CodePAM
Regulation Number 866.3365
Device Class 2


Premarket Reviews
ManufacturerDecision
GREAT BASIN SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICUBATE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1
False Negative Result 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Toxicity 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, LLC II Oct-30-2018
2 Great Basin Scientific, Inc. II Jan-19-2017
3 Luminex Corporation II Aug-10-2020
4 Luminex Corporation III Feb-11-2019
5 Luminex Corporation II Nov-10-2018
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