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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assay, genotype, hiv drug resistance, in vitro
Definition Hiv-1 drug resistance genotyping
Product CodeNHS
Regulation Number 866.3950
Device Class 2


Premarket Reviews
ManufacturerDecision
CELERA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 2 2
High Test Results 2 2
Device Operates Differently Than Expected 1 1
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Consequences Or Impact To Patient 2 2

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