Cell Isolator V2

GUDID 08800021900172

Cytogen, Inc.

Multichannel immunoassay analyser IVD
Primary Device ID08800021900172
NIH Device Record Key51c28b8a-ffba-484d-bb7b-2a763b4befe6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCell Isolator V2
Version Model NumberCIS060
Company DUNS688482626
Company NameCytogen, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+827052213923
Emailhjjeong@cytogenlab.com
Phone+827052213923
Emailhjjeong@cytogenlab.com
Phone+827052213923
Emailhjjeong@cytogenlab.com
Phone+827052213923
Emailhjjeong@cytogenlab.com
Phone+827052213923
Emailhjjeong@cytogenlab.com
Phone+827052213923
Emailhjjeong@cytogenlab.com
Phone+827052213923
Emailhjjeong@cytogenlab.com
Phone+827052213923
Emailhjjeong@cytogenlab.com
Phone+827052213923
Emailhjjeong@cytogenlab.com
Phone+827052213923
Emailhjjeong@cytogenlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800021900172 [Primary]

FDA Product Code

GKHApparatus, Automated Blood Cell Diluting

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-16
Device Publish Date2026-03-06

Devices Manufactured by Cytogen, Inc.

08800021900172 - Cell Isolator V22026-03-16
08800021900172 - Cell Isolator V22026-03-16
08800021900011 - Smart Biopsy™ IF Stainer2023-05-23
08800021900028 - Smart Biopsy™ Isolation Kit2023-05-23
08800021900035 - Smart Biopsy™ Cell Isolator2023-05-16

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