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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device microscope, automated, image analysis, immunohistochemistry,operator intervention,nuclear intensity & percent positivity
Definition Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.
Product CodeNQN
Regulation Number 864.1860
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 1 1
Application Program Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Roche Molecular Systems, Inc. II Jan-17-2021
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