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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device immunohistochemistry assay, antibody, anaplastic lymphoma kinase
Definition The anaplastic lymphoma kinase (ALK) antibody is a qualitative immunohistochemical antibody intended to identify ALK protein expression in human clinical tissue specimens. The ALK antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Product CodePKW
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
2 2 4 2 1 1

MDR Year MDR Reports MDR Events
2018 2 2
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 2 2
False Positive Result 1 1
None 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Therapeutic Effects, Unexpected 1 1
Misdiagnosis 1 1
No Known Impact Or Consequence To Patient 1 1
Cancer 1 1
Test Result 1 1

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