• 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 epstein-barr virus, other
Regulation Description Epstein-Barr virus serological reagents.
Product CodeLSE
Regulation Number 866.3235
Device Class 1


Premarket Reviews
ManufacturerDecision
DIASORIN
  SUBSTANTIALLY EQUIVALENT 2
DIASORIN S.P.A
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Use of Device Problem 1
Use of Incorrect Control Settings 1
Total Device Problems 2

Recalls
Manufacturer Recall Class Date Posted
1 Diamedix Corporation II May-16-2016

-
-