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 nitrophenylphosphate, alkaline phosphatase or isoenzymes
Regulation Description Alkaline phosphatase or isoenzymes test system.
Product CodeCJE
Regulation Number 862.1050
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT LABORATORIES DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
TRUVIAN HEALTH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 6 7
2023 11 12
2024 11 11
2025 10 10
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 21 23
High Test Results 21 21
Incorrect Measurement 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Low Test Results 3 3
Material Integrity Problem 2 2
Chemical Problem 1 1
Output Problem 1 1
Computer Software Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 43

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
2 Ortho-Clinical Diagnostics, INc. II Sep-21-2023
-
-