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

Product Code: PIV

Immunology General Optical Products / Medical

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 Genera

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 866.4750


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as PIV

3104Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical UseAutomated Indirect Immunofluorescence Microscope And Software-assisted System.

Total Product Life Cycle (TPLC) Devices

3104Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical UseAutomated Indirect Immunofluorescence Microscope And Software-assisted System.

Pre-market Notifications for PIV

K153150AUTOLoader, And NOVA View With Models: ALDR1000, AND NV2000Inova Diagnostics, Inc.

Global Unique Device Identification Database

04049016135975Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
04049016135968Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
04049016135951Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
04049016135944Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
04049016135937Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
04049016135920Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
04049016135913Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
04049016135906Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
04049016135890Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
04049016135883Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
04049016135876Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
04049016135869Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
04049016135852Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
04049016135845Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
04049016135838Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

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