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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, androstenedione
Regulation Description Androstenedione test system.
Product CodeCIZ
Regulation Number 862.1075
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1
No Information 1 1

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