AQUIOS IMMUNO-TROL Cells B23535

GUDID 15099590225759

AQUIOS Immuno-Trol Cells

BECKMAN COULTER IRELAND INC.

Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control

• Primary Device ID: 15099590225759
• NIH Device Record Key: 4e0edf78-1dbf-4fc1-a66e-b2730eb363ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUIOS IMMUNO-TROL Cells
• Version Model Number: B23535
• Catalog Number: B23535
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	15099590225759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141932

FDA Product Code

• OYE: Flow Cytometric Reagents And Accessories.

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: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by BECKMAN COULTER IRELAND INC.

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• 10837461002239 - Iris®: 2023-10-13 Iris® Diluent Pack (NA)
• 10837461002260 - Iris®: 2023-10-13 Iris® System Cleanser Pack (NA/INTL)
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• 10837461002345 - iQ®200: 2023-10-13 iQ® Body Fluids Controls-Level I and Level II (NA/INTL)
• 10837461002376 - iQ®200: 2023-10-13 iQ® Lamina™ Case of 2 x 7 L