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) | 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 antisera, all types, h. influenza
Product CodeGRP
Regulation Number 866.3300
Device Class 2

MDR Year MDR Reports MDR Events
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6

Recalls
Manufacturer Recall Class Date Posted
1 The Binding Site Group, Ltd. II Mar-11-2020
-
-