Oncomine™ Dx Target Test

GUDID 10190302015103

LIFE TECHNOLOGIES CORPORATION

Multiple tissue-associated protein/tumour marker IVD, reagent

• Primary Device ID: 10190302015103
• NIH Device Record Key: dbb11fce-bd4d-4b46-9312-2b20e91e9676
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oncomine™ Dx Target Test
• Version Model Number: A32441
• 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: 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	10190302015103 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-30
• Device Publish Date: 2019-05-22

On-Brand Devices [Oncomine™ Dx Target Test]

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