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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nadh oxidation/nad reduction, ast/sgot
Product CodeCIT
Regulation Number 862.1100
Device Class 2


Premarket Reviews
ManufacturerDecision
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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 8 8
Non Reproducible Results 6 6
Low Test Results 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Incorrect Or Inadequate Test Results 2 2
Signal Artifact/Noise 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
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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