Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
Medical specialty
Immunology
Device class
2
Regulation number
866.4750
Review panel
IM
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
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.