Resolution ctDx FIRST Sample Collection Kit

GUDID 00850059806005

Resolution Bioscience, Inc.

Venous blood collection kit IVD

• Primary Device ID: 00850059806005
• NIH Device Record Key: 07e2a3e8-0b6a-4e88-b957-38bdf45c346b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resolution ctDx FIRST Sample Collection Kit
• Version Model Number: 500029
• Company DUNS: 079831618
• Company Name: Resolution Bioscience, Inc.
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850059806005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P210040

FDA Product Code

• PQP: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

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: 2024-04-08
• Device Publish Date: 2024-03-31