AQUIOS IMMUNO-TROL Cells B23535

GUDID 15099590225759

AQUIOS Immuno-Trol Cells

BECKMAN COULTER IRELAND INC.

Multiple CD cell marker IVD, control
Primary Device ID15099590225759
NIH Device Record Key4e0edf78-1dbf-4fc1-a66e-b2730eb363ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameAQUIOS IMMUNO-TROL Cells
Version Model NumberB23535
Catalog NumberB23535
Company DUNS985071975
Company NameBECKMAN COULTER IRELAND 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
GS115099590225759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OYEFlow Cytometric Reagents And Accessories.

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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