IH-Card Neutral 813611100

GUDID 07611969952229

Gel card for use with the IH system; Card for antibody detection of human red blood cells; 48 cards of 6 microtubes

Bio-Rad Medical Diagnostics GmbH

ABO/Rh(D) multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination ABO/Rh multiple blood grouping IVD, kit, agglutination

• Primary Device ID: 07611969952229
• NIH Device Record Key: 121e3679-87f7-484e-88ac-d255e80b6ed4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IH-Card Neutral
• Version Model Number: 813611100
• Catalog Number: 813611100
• 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
• 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 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611969952229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK140138

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-20

On-Brand Devices [IH-Card Neutral]

• 07611969964871: Gel card for use with the IH system; Card for antibody detection of human red blood cells; 288 c
• 07611969964864: Gel card for use with the IH system; Card for antibody detection of human red blood cells; 12 ca
• 07611969952229: Gel card for use with the IH system; Card for antibody detection of human red blood cells; 48 ca