Geenius 12012484

GUDID 03610522162260

Geenius Software V2.0 LIS Guide, US only

Bio-RAD Laboratories, Inc.

HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 03610522162260
• NIH Device Record Key: 27394658-8ccb-4345-a34e-9722c125b0e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geenius
• Version Model Number: 12012484
• Catalog Number: 12012484
• Company DUNS: 844766394
• Company Name: Bio-RAD Laboratories, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: Techsupport.ussd-redmond@bio-rad.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610522162260 [Primary]

FDA Product Code

• QHM: Serology tests used for infectious disease screening of blood and plasma donations

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-07
• Device Publish Date: 2023-07-28

On-Brand Devices [Geenius]

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