iQ200 700-3375

GUDID 10837461001355

"iQ200 Elite 2008 Tested; 800-3934 iQ®200 Elite Plus (US) (2008 Version) (NA); 800-7714 IRICELL 2000 Plus (NA)"

IRIS INTERNATIONAL, INC.

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• Primary Device ID: 10837461001355
• NIH Device Record Key: 16f1ebc6-8b08-426e-9fd7-3345e1967c7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iQ200
• Version Model Number: Elite Plus (US) (2008 Version) (NA)
• Catalog Number: 700-3375
• Company DUNS: 098240690
• Company Name: IRIS INTERNATIONAL, 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
GS1	10837461001355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022774

FDA Product Code

• KQO: Automated Urinalysis System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-09-16
• Device Publish Date: 2016-09-07

On-Brand Devices [iQ200]

• 10837461001355: "iQ200 Elite 2008 Tested; 800-3934 iQ®200 Elite Plus (US) (2008 Version) (NA); 800-7714 IRICELL
• 10837461001317: "iQ200 Select 2008 Instrument; 800-7190 IRICELL 1500 (NA)" "iQ200 Elite 2008 Tested; 800-3052 iQ
• 10837461001300: "iQ200 Select 2008 Tested;800-3935 iQ®200 Select Plus Kit 2008 Analyzer (NA) "iQ200 Select 2008
• 10837461001256: "iQ200 Sprint 2008 Tested; 800-3053 iQ®200 Sprint Pro (NA)" "iQ200 Sprint 2008 Tested; 800-3081