SSP DRB1*08

GUDID 07340035500407

CareDx AB

HLA class II antigen tissue typing IVD, kit, multiplex

• Primary Device ID: 07340035500407
• NIH Device Record Key: 679bb9b1-e117-49f0-93d7-6e49ebce1dc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SSP DRB1*08
• Version Model Number: 101.127-12u
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340035500407 [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 DRB1*08]

• 07340035500421: 101.127-04u
• 07340035500407: 101.127-12u