• 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 assay,enzyme linked immunosorbent,hepatitis c virus
Product CodeMZO
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
5 3 11 12 40 24 16 10 14 1

Device Problems
False negative result 85
Defective item 15
Low test results 10
False positive result 10
No Known Device Problem 6
Incorrect or inadequate test results 6
High test results 3
Spillage, accidental 1
Total Device Problems 136

-
-