LeukoSure Fluorospheres 6607124

GUDID 15099590539788

LeukoSure Enumeration Kit

Beckman Coulter, Inc.

Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent

• Primary Device ID: 15099590539788
• NIH Device Record Key: 9e884f2a-748f-440e-8510-e0117a41fb91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LeukoSure Fluorospheres
• Version Model Number: 6607124
• Catalog Number: 6607124
• Company DUNS: 008254708
• Company Name: Beckman Coulter, 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	15099590539788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK020063

FDA Product Code

• KSF: Kit, Quality Control For Blood Banking Reagents

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

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