CS/CC T8-RD1/T4-FITC (CD4-FITC/CD8-RD1) 6604614

GUDID 15099590539726

CYTO-STAT/COULTER CLONE T8-RD1/T4-FITC

Beckman Coulter, Inc.

Multiple CD cell marker IVD, antibody
Primary Device ID15099590539726
NIH Device Record Key9fd0861e-3618-4bc9-9798-19f360e17808
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS/CC T8-RD1/T4-FITC (CD4-FITC/CD8-RD1)
Version Model Number6604614
Catalog Number6604614
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590539726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, Differential Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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