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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 test, immunoassay, biosensor, hcg
Product CodeNAL
Regulation Number 862.1155
Device Class 2

MDR Year MDR Reports MDR Events
2015 1 1
2016 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 11 11
Incorrect Or Inadequate Test Results 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 6 6
No Known Impact Or Consequence To Patient 3 3
Abdominal Pain 2 2
Test Result 1 1
Fever 1 1
Pain 1 1

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