Oncomine™ Dx Target Test User Guides and Assay Definition File

GUDID 10190302006071

LIFE TECHNOLOGIES CORPORATION

Human genomic analysis interpretive software

• Primary Device ID: 10190302006071
• NIH Device Record Key: a6afdd77-c6f0-48bc-ae9d-3b97490a06e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oncomine™ Dx Target Test User Guides and Assay Definition File
• Version Model Number: A32461
• Company DUNS: 080131636
• Company Name: LIFE TECHNOLOGIES CORPORATION
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	10190302006071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160045

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-11-23
• Device Publish Date: 2017-06-27

On-Brand Devices [Oncomine™ Dx Target Test User Guides and Assay Definition File]

• 10190302006071: A32461
• 10190302017756: A51694