ABC SSPtray 826240

GUDID 07611969953318

for 24 determinations of HLA-ABC alleles; For In Vitro Diagnostic Use

Bio-Rad Medical Diagnostics GmbH

HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 07611969953318
• NIH Device Record Key: dedd2255-7ef8-46f7-b1ee-41758cd525ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABC SSPtray
• Version Model Number: 826240
• Catalog Number: 826240
• 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: true
• 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
• 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 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611969953318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK020004

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-01

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