Image Navigator®

GUDID M749IN2201

Automated microscope system for immunofluorescent determination of autoantibodies.

IMMUNO CONCEPTS INC

Cell morphology analyser IVD, automated

• Primary Device ID: M749IN2201
• NIH Device Record Key: 49fd4657-1539-4227-afbc-2b21fa82ca88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Image Navigator®
• Version Model Number: IN220
• Company DUNS: 038271904
• Company Name: IMMUNO CONCEPTS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M749IN2201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160265

FDA Product Code

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

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-13
• Device Publish Date: 2019-04-08

On-Brand Devices [Image Navigator®]

• M749IN2201: Automated microscope system for immunofluorescent determination of autoantibodies.
• M749IN1101: Automated microscope system for immunofluorescent determination of autoantibodies.
• M74900IN1101: Automated microscope system for immunofluorescent determination of autoantibodies.
• M74900IN2201: Automated microscope system for immunofluorescent determination of autoantibodies.