• 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 Back To Search Results
Device kit, screening, staphylococcus aureus
Regulation Description Microorganism differentiation and identification device.
Product CodeJWX
Regulation Number 866.2660
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
TRINITY
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 2
User used incorrect product for intended use 1
Total Device Problems 3

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 2 0 1 0 0 0 0
Class III 0 0 1 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 NERL Diagnostics Corporation II Mar-12-2010
2 Remel, Inc II Feb-23-2010
3 Remel, Inc III Mar-20-2009
4 bioMerieux, Inc. II Feb-16-2012

-
-