ClearLLab 10C

GUDID 15099590694975

ClearLLab Control Cells abnormal

BECKMAN COULTER IRELAND INC.

Multiple CD cell marker IVD, control

• Primary Device ID: 15099590694975
• NIH Device Record Key: 38ee3bc5-2736-4d72-8add-5be4dfcf886b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearLLab 10C
• Version Model Number: B90003
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590694975 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183592

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-03
• Device Publish Date: 2019-03-26

On-Brand Devices [ClearLLab 10C]

• 15099590701505: ClearLLab 10C M2 Cell Tube
• 15099590701499: ClearLLab 10C M1 Cell Tube
• 15099590701482: ClearLLab 10C T Cell Tube
• 15099590701475: ClearLLab 10C B Cell Tube
• 15099590694982: ClearLLab Compensation Beads
• 15099590694975: ClearLLab Control Cells abnormal
• 15099590694968: ClearLLab 10C Control Cells normal