CC MsIgG1-RD1 6602884

GUDID 15099590542511

COULTER CLONE MsIgG1-RD1

Beckman Coulter, Inc.

Multiple CD cell marker IVD, control
Primary Device ID15099590542511
NIH Device Record Key199c45f1-a273-48b9-84e5-5539ef485f1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCC MsIgG1-RD1
Version Model Number6602884
Catalog Number6602884
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
GS115099590542511 [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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