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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nad reduction/nadh oxidation, cpk or isoenzymes
Regulation Description Creatine phosphokinase/creatine kinase or isoenzymes test system.
Product CodeCGS
Regulation Number 862.1215
Device Class 2

MDR Year MDR Reports MDR Events
2022 1 1
2024 1 1
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 4 4
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4

Recalls
Manufacturer Recall Class Date Posted
1 GET TESTED INTERNATIONAL AB II Dec-01-2025
2 Randox Laboratories Ltd. III May-16-2022
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