PIV · Class II · 21 CFR 866.4750

FDA Product Code PIV: Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use

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.

2
Total
1
Cleared
69d
Avg days
2015
Since

FDA 510(k) Cleared Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use Devices (Product Code PIV)

2 devices
1–2 of 2
No devices found for this product code.

About Product Code PIV - Regulatory Context