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, cannabinoids
Regulation Description Cannabinoid test system.
Product CodeLDJ
Regulation Number 862.3870
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 8
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
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 - CLIA SUBMISSION 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 12
  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 0 0 0
Class III 0 2 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 OraSure Technologies, Inc. III Dec-23-2008
2 OraSure Technologies, Inc. III Dec-18-2008

-
-