Geenius 12012851

GUDID 03610522168064

Geenius SW V2.0 & APF V2.0 Installation Kit

Bio-RAD Laboratories, Inc.

HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Primary Device ID03610522168064
NIH Device Record Key619cf42a-f5bb-418f-b193-04ad802b0a89
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeenius
Version Model Number12012851
Catalog Number12012851
Company DUNS844766394
Company NameBio-RAD Laboratories, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
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+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com
Phone+1(800)224-6723
EmailTechSupport.USSD@bio-rad.com

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Device Identifiers

Device Issuing AgencyDevice ID
GS103610522168064 [Primary]

FDA Product Code

QHMSerology tests used for infectious disease screening of blood and plasma donations

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-07
Device Publish Date2023-07-28

On-Brand Devices [Geenius]

03610522168064Geenius SW V2.0 & APF V2.0 Installation Kit
03610522162260Geenius Software V2.0 LIS Guide, US only
03610522162239Geenius Blood Donor IFU & APF v2.0 binder
03610521168942Geenius HIV 1/2 Supplemental Assay 20t

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