Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device test, factor v leiden mutations, genomic dna pcr
Definition In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Product CodeNPQ
Regulation Number 864.7280
Device Class 2


Premarket Reviews
ManufacturerDecision
CEPHEID
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ILLUMINA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSMETECH MOLECULAR DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. II Mar-14-2011
2 Roche Molecular Systems, Inc. II Jun-14-2011
3 Synthes Spine II Feb-03-2009
4 Zimmer, Inc. II Nov-06-2012
-
-