Smart Biopsy™ Isolation Kit

GUDID 08800021900028

Cytogen, Inc.

Red blood cell separation reagent

• Primary Device ID: 08800021900028
• NIH Device Record Key: a4ecd0d1-1b07-4db6-b596-32c2339c227d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Biopsy™ Isolation Kit
• Version Model Number: CIKW10
• Company DUNS: 688482626
• Company Name: Cytogen, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +827052213923
• Email: cgkim@cytogenlab.com
• Phone: +827052213923
• Email: cgkim@cytogenlab.com
• Phone: +827052213923
• Email: cgkim@cytogenlab.com
• Phone: +827052213923
• Email: cgkim@cytogenlab.com
• Phone: +827052213923
• Email: cgkim@cytogenlab.com
• Phone: +827052213923
• Email: cgkim@cytogenlab.com
• Phone: +827052213923
• Email: cgkim@cytogenlab.com
• Phone: +827052213923
• Email: cgkim@cytogenlab.com
• Phone: +827052213923
• Email: cgkim@cytogenlab.com
• Phone: +827052213923
• Email: cgkim@cytogenlab.com
• Phone: +827052213923
• Email: cgkim@cytogenlab.com
• Phone: +827052213923
• Email: cgkim@cytogenlab.com
• Phone: +827052213923
• Email: cgkim@cytogenlab.com
• Phone: +827052213923
• Email: cgkim@cytogenlab.com
• Phone: +827052213923
• Email: cgkim@cytogenlab.com
• Phone: +827052213923
• Email: cgkim@cytogenlab.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 26 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800021900028 [Primary]

FDA Product Code

• GKH: Apparatus, Automated Blood Cell Diluting

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: 2023-05-23
• Device Publish Date: 2023-05-15

Devices Manufactured by Cytogen, Inc.

• 08800021900011 - Smart Biopsy™ IF Stainer: 2023-05-23
• 08800021900028 - Smart Biopsy™ Isolation Kit: 2023-05-23
• 08800021900028 - Smart Biopsy™ Isolation Kit: 2023-05-23
• 08800021900035 - Smart Biopsy™ Cell Isolator: 2023-05-16