Smart Biopsy™ Isolation Kit

GUDID 08800021900028

Cytogen, Inc.

Red blood cell separation reagent Red blood cell separation reagent Red blood cell separation reagent Red blood cell separation reagent Red blood cell separation reagent Red blood cell separation reagent Red blood cell separation reagent Red blood cell separation reagent Red blood cell separation reagent Red blood cell separation reagent Red blood cell separation reagent Red blood cell separation reagent Red blood cell separation reagent Red blood cell separation reagent Red blood cell separation reagent 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