Smart Biopsy™ IF Stainer

GUDID 08800021900011

Cytogen, Inc.

Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD

• Primary Device ID: 08800021900011
• NIH Device Record Key: fca5ad47-d4ef-4824-972f-bcd860ea618a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Biopsy™ IF Stainer
• Version Model Number: CST030
• 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: false
• Device Combination Product: false
• Single Use: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800021900011 [Primary]

FDA Product Code

• KPA: Slide Stainer, Automated

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