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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device enzyme immunoassay, opiates
Regulation Description Opiate test system.
Product CodeDJG
Regulation Number 862.3650
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 5
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 6
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
ORASURE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
PHAMATECH
  SUBSTANTIALLY EQUIVALENT 3
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 6
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Express Diagnostics Int'l., Inc. II May-27-2011

-
-