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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device control material, her-2/neu, immunohistochemistry
Definition Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays.
Product CodeNJW
Regulation Number 864.1860
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON CELL STANDARDS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Failure To Adhere Or Bond 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 1 1
Joint Laxity 1 1

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