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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, factor ii g20210a mutations, genomic dna pcr
Definition In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Product CodeNPR
Regulation Number 864.7280
Device Class 2


Premarket Reviews
ManufacturerDecision
CEPHEID®
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE MOLECULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 1 1
Improper or Incorrect Procedure or Method 1 1
Incorrect Or Inadequate Test Results 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Stenosis 1 1
No Known Impact Or Consequence To Patient 1 1
Valvular Stenosis 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. II Mar-14-2011
2 Roche Molecular Systems, Inc. II Mar-05-2010
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