MLB 2 805200100

GUDID 07611969950898

Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml

Bio-Rad Medical Diagnostics GmbH

Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

• Primary Device ID: 07611969950898
• NIH Device Record Key: 9a4871ad-1662-4903-a77e-1ae6b7293272
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MLB 2
• Version Model Number: 805200100
• Catalog Number: 805200100
• Company DUNS: 312576506
• Company Name: Bio-Rad Medical Diagnostics GmbH
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-224-6723
• Email: techsupport.bmd@bio-rad.com
• Phone: 800-224-6723
• Email: techsupport.bmd@bio-rad.com
• Phone: 800-224-6723
• Email: techsupport.bmd@bio-rad.com
• Phone: 800-224-6723
• Email: techsupport.bmd@bio-rad.com
• Phone: 800-224-6723
• Email: techsupport.bmd@bio-rad.com
• Phone: 800-224-6723
• Email: techsupport.bmd@bio-rad.com
• Phone: 800-224-6723
• Email: techsupport.bmd@bio-rad.com
• Phone: 800-224-6723
• Email: techsupport.bmd@bio-rad.com
• Phone: 800-224-6723
• Email: techsupport.bmd@bio-rad.com
• Phone: 800-224-6723
• Email: techsupport.bmd@bio-rad.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611969950898 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK040070

FDA Product Code

• KSZ: System, Test, Automated Blood Grouping And Antibody

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-12
• Device Publish Date: 2015-07-01

On-Brand Devices [MLB 2]

• 07611969965748: Modified LISS-Enhancement media for TANGO instruments and tube test; 10x10mL
• 07611969965731: Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml
• 07611969950911: Modified LISS-Enhancement media for TANGO® optimo and tube test; 10x10ml
• 07611969950898: Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml