Oncomine™ Dx Target Test

GUDID 10190302006385

ONC UNIV DX RNA/DNA PANEL IVD

LIFE TECHNOLOGIES CORPORATION

Multiple tissue-associated protein/tumour marker IVD, reagent

• Primary Device ID: 10190302006385
• NIH Device Record Key: 6d0fab78-a58c-4663-b4cd-7fe1f9f68b2a
• Commercial Distribution Discontinuation: 2019-03-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Oncomine™ Dx Target Test
• Version Model Number: A32441
• Company DUNS: 790376870
• Company Name: LIFE TECHNOLOGIES CORPORATION
• Device Count: 48
• 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: 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	10190302006385 [Primary]
GS1	80190302006384 [Unit of Use]

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: 6
• Public Version Date: 2025-02-11
• Device Publish Date: 2017-06-27

On-Brand Devices [Oncomine™ Dx Target Test]

• 10190302015103: A32441
• 10190302006385: ONC UNIV DX RNA/DNA PANEL IVD