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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme linked immunosorbent assay, t. cruzi
Product CodeMIU
Regulation Number 866.3870
Device Class 1


Premarket Reviews
ManufacturerDecision
INBIOS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 2 2
2016 5 5
2017 5 5
2018 3 3
2019 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 9 9
High Test Results 9 9
Low Test Results 2 2
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 14 14
No Consequences Or Impact To Patient 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Wiener Laboratories II Mar-07-2018
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