iQ®200 800-3704

GUDID 10837461002475

iQ®200 Body Fluids Module (CD only)

IRIS INTERNATIONAL, INC.

Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD

• Primary Device ID: 10837461002475
• NIH Device Record Key: 8103f61d-c534-4276-96f9-ee6e14572709
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iQ®200
• Version Model Number: Body Fluids Module
• Catalog Number: 800-3704
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	10837461002475 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050235

FDA Product Code

• GKL: Counter, Cell, Automated (Particle Counter)

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: 2022-03-22
• Device Publish Date: 2016-09-07

On-Brand Devices [iQ®200 ]

• 10837461002475: iQ®200 Body Fluids Module (CD only)
• 10837461002192: iQ® Lamina™ Cradle
• 10837461002116: iQ® Lamina™ Case of 4 x 7 L