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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device automated indirect immunofluorescence microscope and software-assisted system for clinical use
Definition Automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescent technology. A trained operator must confirm all device generated results.
Product CodePIV
Regulation Number 866.4750
Device Class 2


Premarket Reviews
ManufacturerDecision
INOVA DIAGNOSTICS, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

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