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 test, antigen, nuclear, epstein-barr virus
Regulation Description Epstein-Barr virus serological reagents.
Product CodeLLM
Regulation Number 866.3235
Device Class 1


Premarket Reviews
ManufacturerDecision
DIASORIN
  SUBSTANTIALLY EQUIVALENT 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 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Diasorin Inc. III Apr-24-2007

-
-