IRISpec 800-7702

GUDID 10837461002680

IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS

BECKMAN COULTER IRELAND INC.

Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control

• Primary Device ID: 10837461002680
• NIH Device Record Key: 421b7ef5-844f-4ab7-a747-ef6caa42d2e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRISpec
• Version Model Number: CA/CB/CC URINE CHEMSITRY CONTROLS
• Catalog Number: 800-7702
• 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	10837461002680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072640

FDA Product Code

• JJW: Urinalysis Controls (Assayed And Unassayed)

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 [IRISpec]

• 10837461002680: IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS
• 10837461002611: IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS