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.

Leading manufacturers include Inova Diagnostics, Inc..

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
Cleared Nov 24, 2015
AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
K153150
Inova Diagnostics, Inc.
Immunology · 22d
Not Cleared Apr 09, 2015
NOVA View Automated Fluorescense Microscope
DEN140039
Inova Diagnostics, Inc.
Immunology · 115d

About Product Code PIV - Regulatory Context