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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device erythrocyte suspension, multi species, serological reagent and equipment
Regulation Description Streptococcus spp. exoenzyme reagents.
Product CodeLHW
Regulation Number 866.3720
Device Class 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 1 1
False Positive Result 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1
No Patient Involvement 1 1
No Information 1 1

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