Lymphoscreen ABC-60

GUDID 07611969965700

Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependend microlymphocytotoxicity test

Bio-Rad Medical Diagnostics GmbH

HLA class I antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)

• Primary Device ID: 07611969965700
• NIH Device Record Key: 41922d47-594c-4672-b29b-740d7c393ad6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lymphoscreen ABC-60
• Version Model Number: 823300
• 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
• 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 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611969965700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK980033

FDA Product Code

• MZI: Test,Qualitative,For Hla,Non-Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-08

On-Brand Devices [Lymphoscreen ABC-60]

• 07611969965700: Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependend micro
• 07611969952939: Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependent micro