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TPLC
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show TPLC since
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Device
nadh oxidation/nad reduction, ast/sgot
Product Code
CIT
Regulation Number
862.1100
Device Class
2
Premarket Reviews
Manufacturer
Decision
SEPPIM S.A.S.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2017
2
2
2018
1
1
2019
2
2
2020
1
1
2021
5
5
2022
2
2
2023
2
2
2024
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
8
8
Non Reproducible Results
8
8
Low Test Results
4
4
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Incorrect Or Inadequate Test Results
2
2
Unable to Obtain Readings
1
1
Signal Artifact/Noise
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
16
16
No Consequences Or Impact To Patient
6
6
No Known Impact Or Consequence To Patient
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories Inc.
II
Apr-23-2012
2
Alfa Wassermann, Inc.
II
Apr-30-2014
3
ELITech Clinical Systems SAS
III
Oct-02-2014
4
Horiba Instruments, Inc dba Horiba Medical
II
Jan-03-2013
5
Medtest Holdings, Inc.
III
May-18-2017
6
Ortho-Clinical Diagnostics
II
Nov-15-2013
7
Randox Laboratories Ltd.
II
Oct-31-2023
8
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
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