• 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 turbidimetric, total protein
Product CodeJGQ
Regulation Number 862.1635
Device Class 2

MDR Year MDR Reports MDR Events
2019 5 5
2020 2 2
2021 2 2
2022 1 1
2023 7 7
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 8 8
Low Test Results 6 6
Non Reproducible Results 6 6
Incorrect, Inadequate or Imprecise Result or Readings 2 2
False Positive Result 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
No Consequences Or Impact To Patient 5 5
No Known Impact Or Consequence To Patient 1 1
No Code Available 1 1

-
-