HLA-B*51

GUDID 07340035504108

CareDx AB

HLA class I antigen tissue typing IVD, kit, multiplex

• Primary Device ID: 07340035504108
• NIH Device Record Key: aa15137f-aa3a-4a26-98de-71d5d51993cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HLA-B*51
• Version Model Number: 101.561-03u
• Company DUNS: 558836388
• Company Name: CareDx AB
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340035504108 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-26
• Device Publish Date: 2023-07-18

On-Brand Devices [HLA-B*51]

• 07340035504108: 101.561-03u
• 07340035504085: 101.561-24u