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 test, urine leukocyte
Regulation Description Leukocyte peroxidase test.
Product CodeLJX
Regulation Number 864.7675
Device Class 1


Premarket Reviews
ManufacturerDecision
HEALGEN SCIENTIFIC,, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 1 1
2023 5 5
2024 1 1
2025 7 7
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 6 6
Inadequate Instructions for Non-Healthcare Professional 2 2
Device Difficult to Setup or Prepare 2 2
Non Reproducible Results 1 1
Incorrect Measurement 1 1
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Urinary Tract Infection 6 6
Insufficient Information 2 2
Pain 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Changchun Wancheng Bio-Electron Co., Ltd. II Feb-04-2026
2 DFI Co., Ltd. II May-06-2026
3 GET TESTED INTERNATIONAL AB II Dec-01-2025
-
-