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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
Regulation Description Aspartate amino transferase (AST/SGOT) test system.
Product CodeCIT
Regulation Number 862.1100
Device Class 2

Device Problems
Incorrect Or Inadequate Test Results 6
High Test Results 3
Probe 1
Low Test Results 1
Total Device Problems 11

Recalls
Manufacturer Recall Class Date Posted
1 Alfa Wassermann, Inc. II Apr-30-2014
2 ELITech Clinical Systems SAS III Oct-02-2014
3 Medtest Holdings, Inc. III May-18-2017
4 Siemens Healthcare Diagnostics, Inc. II May-04-2018

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