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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, cystatin c
Product CodeNDY
Regulation Number 862.1225
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 2 2
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Gentian AS II Oct-13-2020
2 Randox Laboratories Ltd. II Mar-22-2024
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