PIV

Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Product code

PIV

Device name

Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Device class

Class 2

21 CFR

21 CFR 866.4750

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).