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 Type: Optical
• Radition Safety: None
• Annual Reports: No

Products Classified as PIV

3104

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

Automated Indirect Immunofluorescence Microscope And Software-assisted System.

Total Product Life Cycle (TPLC) Devices

3104

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

Automated Indirect Immunofluorescence Microscope And Software-assisted System.

Pre-market Notifications for PIV

K153150

AUTOLoader, And NOVA View With Models: ALDR1000, AND NV2000

Inova Diagnostics, Inc.

Global Unique Device Identification Database

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