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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
urease and glutamic dehydrogenase, urea nitrogen
Product Code
CDQ
Regulation Number
862.1770
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT IRELAND DIAGNOSTICS DIVISION
SUBSTANTIALLY EQUIVALENT
1
MEDICA CORP.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2016
231
231
2020
3
3
2021
1
1
2022
1
1
2023
2
2
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Low Test Results
216
216
High Test Results
201
201
Incorrect Or Inadequate Test Results
10
10
Nonstandard Device
8
8
Non Reproducible Results
5
5
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Mechanical Problem
2
2
Therapeutic or Diagnostic Output Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
229
229
No Clinical Signs, Symptoms or Conditions
7
7
No Consequences Or Impact To Patient
7
7
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories, Inc
II
Nov-16-2011
2
Randox Laboratories Ltd.
II
Aug-09-2023
3
Siemens Healthcare Diagnostics, Inc.
II
Sep-30-2023
4
Siemens Healthcare Diagnostics, Inc.
II
Jun-04-2018
5
Siemens Healthcare Diagnostics, Inc.
II
May-06-2016
-
-