Bromelin for Erytype 806210100

GUDID 07611969965755

Red Blood Cell Diluent for TANGO instruments, 10x10 mL

Bio-Rad Medical Diagnostics GmbH

Bromelin immunohaematology reagent IVD

• Primary Device ID: 07611969965755
• NIH Device Record Key: 4345a91c-5ae1-4a63-85c9-bbee7f92c422
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bromelin for Erytype
• Version Model Number: 806210100
• Catalog Number: 806210100
• 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: true
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611969965755 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-14

On-Brand Devices [Bromelin for Erytype]

• 07611969965755: Red Blood Cell Diluent for TANGO instruments, 10x10 mL
• 07611969951307: Red Blood Cell Diluent for TANGO instruments, 10x10 ml