IH-Com 009100

GUDID 03610520569870

IH-Com Kit Fullversion US; Software Version: 04.0.27.

Bio-Rad Medical Diagnostics GmbH

Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD

• Primary Device ID: 03610520569870
• NIH Device Record Key: 20f66c8b-98c8-47ae-93bc-cd0d1b164b73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IH-Com
• Version Model Number: 04.0.27
• Catalog Number: 009100
• 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: 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610520569870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK140107

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: 2022-03-22
• Device Publish Date: 2017-01-20

Devices Manufactured by Bio-Rad Medical Diagnostics GmbH

• 03610520569870 - IH-Com: 2022-03-22IH-Com Kit Fullversion US; Software Version: 04.0.27.
• 03610520569870 - IH-Com: 2022-03-22 IH-Com Kit Fullversion US; Software Version: 04.0.27.
• 03610522055685 - IH-Card ABO Neutral: 2022-03-17 The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells.
• 07611969964505 - IH-Titration Rack: 2022-03-17 IH-Titration Rack is a rack with empty wells for plasma/serum dilution used with the IH-500.
• 07611969952205 - IH-Titration Solution: 2022-03-11 IH-Titration Solution is a dilution medium for the titer determination of antibodies in patient and donor samples for use with a
• 07611969233786 - IH-500: 2022-01-31 IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of hu
• 03610522123919 - IH-Com V5.2: 2021-02-26 IH-Com V5.2, Software Version 5.2
• 03610522165049 - Wash Solution A Concentrate: 2020-02-13 Wash Solution for use with the IH-500
• 07611969951369 - Alsevers Solution: 2019-11-27 Suspension medium and stabilizer for red blood cells for TANGO instruments and other immunohaematology methods