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 nadh oxidation/nad reduction, ast/sgot
Product CodeCIT
Regulation Number 862.1100
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2021 5 5
2022 2 2
2023 2 2
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 9 9
High Test Results 8 8
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Low Test Results 3 3
Signal Artifact/Noise 1 1
Mechanical Problem 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Randox Laboratories Ltd. II Oct-31-2023
-
-