ClearLLab B66810

GUDID 15099590671006

ClearLLab B2

BECKMAN COULTER IRELAND INC.

Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody

• Primary Device ID: 15099590671006
• NIH Device Record Key: eccab71c-d591-4a59-a429-39feb3fa7623
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearLLab
• Version Model Number: B2
• Catalog Number: B66810
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590671006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN160047

FDA Product Code

• PWD: Flow Cytometric Test System For Hematopoietic Neoplasms

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: 2017-07-06

On-Brand Devices [ClearLLab]

• 15099590671013: ClearLLab M
• 15099590671006: ClearLLab B2
• 15099590670993: ClearLLab B1
• 15099590670986: ClearLLab T2
• 15099590670979: ClearLLab T1