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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State The system may include a fluorescence microscope with light source, a motorized microscope stage, dedicated instrument controls, a camera, a computer, a sample processor, and other hardware components. The software may include fluorescent signal acquisition and processing software, data storage, data transferring mechanisms, and assay specific algorithms to suggest results. A trained operator must confirm results generated with the device.
Technical Method indirect immunofluorescent technology
Target Area human serum
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodePIV
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.4750
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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