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 urease and glutamic dehydrogenase, urea nitrogen
Product CodeCDQ
Regulation Number 862.1770
Device Class 2


Premarket Reviews
ManufacturerDecision
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 3 3

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 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
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 Consequences Or Impact To Patient 7 7
No Clinical Signs, Symptoms or Conditions 5 5
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
-
-