SSP HLA-B low

GUDID 07340035504023

CareDx AB

HLA class I antigen tissue typing IVD, kit, multiplex

• Primary Device ID: 07340035504023
• NIH Device Record Key: 798c83ae-1ab5-4fbd-839e-d7093e27880b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SSP HLA-B low
• Version Model Number: 101.501-48u
• 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	07340035504023 [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 [SSP HLA-B low]

• 07340035504047: 101.501-12u
• 07340035504023: 101.501-48u