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 indicator method, protein or albumin (urinary, non-quant.)
Regulation Description Urinary protein or albumin (nonquantitative) test system.
Product CodeJIR
Regulation Number 862.1645
Device Class 1


Premarket Reviews
ManufacturerDecision
HEALTHY.IO, LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 1 1
2023 2 2
2024 4 4
2025 2 2
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 7 7
False Negative Result 1 1
Output Problem 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1

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 Healgen Scientific Llc II Sep-27-2024
4 Siemens Healthcare Diagnostics, Inc. II Aug-05-2026
5 Siemens Healthcare Diagnostics, Inc. II Mar-02-2026
6 Siemens Healthcare Diagnostics, Inc. II Sep-18-2024
-
-