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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prealbumin, antigen, antiserum, control
Regulation Description Prealbumin immunological test system.
Product CodeJZJ
Regulation Number 866.5060
Device Class 1

MDR Year MDR Reports MDR Events
2017 2 2

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2

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