StemONE software 6915452

GUDID 15099590559519

stemONE

Beckman Coulter, Inc.

Laboratory instrument/analyser application software IVD
Primary Device ID15099590559519
NIH Device Record Keyc551488d-e55f-43a5-91ce-db700f56173e
Commercial Distribution StatusIn Commercial Distribution
Brand NameStemONE software
Version Model Number6915452
Catalog Number6915452
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
GS115099590559519 [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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05099590798980 - MicroScan2025-12-16 MicroScan Neg Combo 104
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