Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.
US Regulatory Classifications
Device Characteristics
No
No
No
Eligible
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.
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