Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
electrode, ion based, enzymatic, creatinine
Regulation Description
Creatinine test system.
Product Code
CGL
Regulation Number
862.1225
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
19
19
2021
20
20
2022
11
11
2023
5
5
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
24
24
Non Reproducible Results
18
18
Low Test Results
9
9
Erratic Results
3
3
Low Readings
3
3
Incorrect Measurement
3
3
Insufficient Information
3
3
Defective Component
2
2
High Test Results
2
2
Smoking
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Fluid/Blood Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
33
33
Insufficient Information
9
9
No Known Impact Or Consequence To Patient
5
5
No Consequences Or Impact To Patient
3
3
Abnormal Blood Gases
2
2
Ischemia Stroke
1
1
Death
1
1
Sepsis
1
1
Premature Labor
1
1
Cancer
1
1
Pain
1
1
Cardiac Arrest
1
1
No Information
1
1
Hematuria
1
1
Sudden Cardiac Death
1
1
Abdominal Pain
1
1
Cardiomyopathy
1
1
-
-