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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioassay, intrinsic factor blocking antibody
Regulation Description Vitamin B[bdi1][bdi2] test system.
Product CodeLIG
Regulation Number 862.1810
Device Class 2

MDR Year MDR Reports MDR Events
2018 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1 1
High Test Results 1 1

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

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