iQ®200 800-3219

GUDID 10837461002345

iQ® Body Fluids Controls-Level I and Level II (NA/INTL)

BECKMAN COULTER IRELAND INC.

Urine sediment IVD, calibrator

• Primary Device ID: 10837461002345
• NIH Device Record Key: 2bd7780f-f227-40ed-9796-468823acef9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iQ®200
• Version Model Number: iQ® Body Fluids Controls-Level I and Level II (NA/
• Catalog Number: 800-3219
• Company DUNS: 985071975
• Company Name: BECKMAN COULTER IRELAND 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	10837461002345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051706

FDA Product Code

• JPK: Mixture, Hematology Quality Control

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: 2023-10-13
• Device Publish Date: 2016-09-07

On-Brand Devices [iQ®200 ]

• 10837461002376: iQ® Lamina™ Case of 2 x 7 L
• 10837461002345: iQ® Body Fluids Controls-Level I and Level II (NA/INTL)
• 10837461002307: iQ® Body Fluids Lysing Reagent (NA/INTL)
• 10837461002178: iQ® Control/Focus Set (NA/INTL)
• 10837461002147: iQ® Calibrator Pack
• 10837461002031: iQ Precision Kit