IH-500 001510

GUDID 07611969233786

IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens

Bio-Rad Medical Diagnostics GmbH

Immunohaematology/blood bank analyser IVD, automated

• Primary Device ID: 07611969233786
• NIH Device Record Key: 702edeb7-5b88-43e9-9bbc-d750cb166f2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IH-500
• Version Model Number: 001510
• Catalog Number: 001510
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611969233786 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK180274

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: 2
• Public Version Date: 2022-01-31
• Device Publish Date: 2019-07-05

Devices Manufactured by Bio-Rad Medical Diagnostics GmbH

• 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: 2022-01-31IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens
• 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