• 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 laboratory developed test
Definition A clinical diagnostic test for use in the diagnosis of disease or other conditions that was developed by CLIA certified clinical laboratory for use in that laboratory. This product is neither an Analyte Specific Reagent nor are the components for Research Use Only. The reporting of adverse events is voluntary and registering and listing is not required.
Product CodeOQS
Device Class Not Classified

Device Problems
Inappropriate shock 1
Total Device Problems 1

-
-